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ANNIVERSARY CELEBRATION ANNUAL MEETING & EXPO AMP2019 CORPORATE WORKSHOP PRELIMINARY November 7-9, 2019 Corporate Workshop Day November 6 Baltimore Convention Center Baltimore, MD, USA

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Page 1: AMP2019& EXPO ANNUAL MEETIN G...Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays Roche 327-329 10:00 AM 10:50 AM Scaling Molecular Laboratory

A N N I V E R S A R Y C E L E B R AT I O N

ANNUAL MEETING & EXPOAMP2019

CORPORATE WORKSHOPPRELIMINARY

November 7-9, 2019

Corporate Workshop DayNovember 6

Baltimore Convention CenterBaltimore, MD, USA

Page 2: AMP2019& EXPO ANNUAL MEETIN G...Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays Roche 327-329 10:00 AM 10:50 AM Scaling Molecular Laboratory

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Page 3: AMP2019& EXPO ANNUAL MEETIN G...Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays Roche 327-329 10:00 AM 10:50 AM Scaling Molecular Laboratory

AMP 2019 ANNIVERSARY CELEBRATION | 1

ANNUAL MEETING & EXPO

WELCOME TO AMP 2019 WORKSHOP DAY! Host Companies

Abbott Molecular*

Adaptive Biotechnologies Corp.*

Agena Bioscience*

Agilent Technologies

Applied BioCode

Arc Bio LLC

ArcherDx

AstraZeneca*

Asuragen*

Beckman Coulter Life Sciences

Biocartis

Biolyph

Bionano Genomics

Bio-Rad Laboratories, Inc.

Bristol Myers Squibb*

ChromaCode

Cofactor Genomics

Contextual Genomics

EntroGen

Epigenomics, Inc.

Genosity

Illumina*

Integrated DNA Technologies

Invivoscribe

LGC, Biosearch Technologies

Loxo Oncology*

Meridian BioScience Inc.

Mission Bio

NanoString Technologies*

NeuMoDx Molecular

Paragon Genomics, Inc.

PerkinElmer

Personal Genome Diagnostics

PierianDx

Pillar Biosciences Inc.

Promega Corporation

Purigen Biosystems, Inc.

QIAGEN*

Quidel Corporation

Rheonix, Inc.*

Roche*

SeraCare Life Sciences, Inc.

SOPHiA GENETICS

STEMCELL Technologies, Inc.

Sunquest Information Systems

Takara Bio USA

Thermo Fisher Scientific*

TriLink BioTechnologies

Twist Bioscience

*AMP Corporate Partner Company

Page 4: AMP2019& EXPO ANNUAL MEETIN G...Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays Roche 327-329 10:00 AM 10:50 AM Scaling Molecular Laboratory

AMP 20192 | ANNIVERSARY CELEBRATION

ANNUAL MEETING & EXPO

NOTES

Page 5: AMP2019& EXPO ANNUAL MEETIN G...Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays Roche 327-329 10:00 AM 10:50 AM Scaling Molecular Laboratory

AMP 2019 ANNIVERSARY CELEBRATION | 3

ANNUAL MEETING & EXPO

AMP 2019 CORPORATE WORKSHOP DAY SCHEDULE AT A GLANCESTART END TITLE HOST ROOM

8:00 AM

8:00 AM 8:50 AMImplementation of Automated Comprehensive NGS Panel at a Community Cancer Center presented by Dr. Qi Wei.

Beckman Coulter Life Sciences 318-320

8:00 AM 8:50 AM Easier and Faster BCR-ABL Monitoring with Cepheid’s Xpert BCR-ABL Ultra Cepheid 344

8:00 AM 8:50 AMNew Oncology Menu for NovaSeq 6000 System: Offers Flexibility for High-throughput Testing of Liquid Biopsy and FFPE Samples

Illumina 308

8:00 AM 8:50 AM Hyb & Seq™ Technology Based Rapid Pathogen Identification and Antibiotic Susceptibility Testing

NanoString Technologies 339

8:00 AM 8:50 AM Automated NGS Bioinformatics for Clinical Oncology – the PGDx elio™ Decentralized Model

Personal Genome Diagnostics 321-323

8:00 AM 8:50 AM Past, Present and Future Advances in MSI Testing Promega Corporation 343

8:00 AM 8:50 AM

From Raw Sample to Sequence-Ready Library: Fully Integrated and Automated Nucleic Acid Extraction and NGS Library Preparation Using the Rheonix NGS OnePrep™ Solution

Rheonix, Inc. 338

8:00 AM 8:50 AM Defining Your Lab’s Diagnostic Strategy for Improved Sexual Health Management Roche 327-329

8:00 AM 8:50 AM

Technical and Regulatory Considerations for Designing Next-Generation Sequencing Controls and Standards for Optimal Quality and Performance: A Panel Discussion

SeraCare Life Sciences, In 309

9:00 AM

9:00 AM 9:50 AM Pharmacogenetic (PGx) Sample Mischaracterization: The Prevalence and Impact of CYP2D6 Hybrid Alleles Agena Bioscience 337

9:00 AM 9:50 AM Rationale for Homologous Recombination Repair (HRR) Deficiency Testing in Select Cancers AstraZeneca 310

9:00 AM 9:50 AMCancer Genomics at Scale to Improve Population Health: A Sonic Laboratories and Contextual Genomics Collaborative Approach

Contextual Genomics 324-326

9:00 AM 9:50 AMNew Oncology Menu for NovaSeq 6000 System: Offers Flexibility for High-throughput Testing of Liquid Biopsy and FFPE Samples

Illumina 308

9:00 AM 9:50 AM IDT Complete Molecular Diagnostics Workflows Integrated DNA Technologies 307

9:00 AM 9:50 AM Quantitative Analysis of Intracellular Signaling Pathways in FFPE Tumor Tissue

NanoString Technologies 339

9:00 AM 9:50 AM

Evaluation of DiaSorin Molecular Enterovirus (EV) and Cytomegalovirus (CMV) Primer Pairs in Laboratory Developed Test (LDT) Implementation on the Open, Random-Access NeuMoDx™ 288 Molecular System

NeuMoDx 340

Page 6: AMP2019& EXPO ANNUAL MEETIN G...Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays Roche 327-329 10:00 AM 10:50 AM Scaling Molecular Laboratory

AMP 20194 | ANNIVERSARY CELEBRATION

ANNUAL MEETING & EXPO

AMP 2019 CORPORATE WORKSHOP DAY SCHEDULE AT A GLANCESTART END TITLE HOST ROOM

9:00 AM (CONTINUED)

9:00 AM 9:50 AMScreening for Mismatch Repair Deficiency in the Era of Immunotherapy. A Single Institution Experience and Lessons Learned

Promega Corporation 343

9:00 AM 9:50 AM The Dual Trend of Centralization and Decentralization: How Should Your Lab Adapt? Roche 327-329

9:00 AM 9:50 AM Expand Molecular Profiling in NSCLC for Existing and Emerging Biomarkers Thermo Fisher Scientific 314-315

10:00 AM

10:00 AM 10:50 AM Simple, Sensitive, and Scalable Patient Monitoring with the QuantideX® qPCR BCR-ABL IS Kit Asuragen 338

10:00 AM 10:50 AM

Overcoming Challenges of MYB-NFIB Gene Fusion Detection from FFPE Adenoid Cystic Carcinoma Tissues Employing nCounter® Analysis; An Exploratory Study

NanoString Technologies 339

10:00 AM 10:50 AM Development and Validation of a Novel Diagnostic Test for Non-Alcoholic Steatohepatitis (NASH) Promega Corporation 343

10:00 AM 10:50 AM Syndromic Solutions to Aid Therapeutic Decision Making for Patients with Respiratory Infection QIAGEN 316-317

10:00 AM 10:50 AM Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays Roche 327-329

10:00 AM 10:50 AM Scaling Molecular Laboratory Diagnostics for Volume, Efficiency, and Compliance

Sunquest Information Systems 321-323

10:00 AM 10:50 AM Workflow Solutions for Streamlining Your Assays Using Clinically-relevant Sample Types Takara Bio USA 309

10:00 AM 10:50 AMLatest Case Studies and Innovations in Solid Tumor Clinical Research for Targeted and Immuno-oncology Biomarkers

Thermo Fisher Scientific 314-315

11:00 AM

11:00 AM 11:50 AMAdvancing Patient Care in Solid Tumors: Innovative Biomarker-based Approaches to Molecular Diagnostics

Abbott Molecular 337

11:00 AM 11:50 AM Enabling NGS-based Metagenomics in the Clinical Microbiology Laboratory Arc Bio LLC 345-346

11:00 AM 11:50 AMMultiplexing Multiplied: How ChromaCode is Revolutionizing Multiplex Real-Time and Digital PCR Testing with Data Science

ChromaCode 324-326

11:00 AM 11:50 AM

Finding Flexibility in a Resource Limited World: Considerations for Amplicon-based NGS Enrichment in Laboratories Running Multiple Sample and Assay Types

Pillar Biosciences Inc. 340

11:00 AM 11:50 AM Rapid Molecular Testing for Influenza Using Solana Quidel Corporation 347-348

Page 7: AMP2019& EXPO ANNUAL MEETIN G...Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays Roche 327-329 10:00 AM 10:50 AM Scaling Molecular Laboratory

AMP 2019 ANNIVERSARY CELEBRATION | 5

ANNUAL MEETING & EXPO

AMP 2019 CORPORATE WORKSHOP DAY SCHEDULE AT A GLANCESTART END TITLE HOST ROOM

11:00 AM (CONTINUED)

11:00 AM 11:50 AM AVENIO ctDNA Clinical Research Story: Surveillance & Monitoring Roche 327-329

11:00 AM 11:50 AM Increasing the Resolution of Molecular Cytogenetic Analyses Through Cell Enrichment

STEMCELL Technologies, Inc. 307

11:00 AM 11:50 AMNext-Generation Sequencing (NGS) in Hematology-oncology Clinical Research: From Initial Assessment to MRD

Thermo Fisher Scientific 314-315

12:00 PM

12:00 PM 12:50 PM Impact of Quality Processes for Staging and Biomarker Testing on Care of Patients with NSCLC AstraZeneca 310

12:00 PM 12:50 PMFrom Two Days to Four Hours: How the AmplideX® PCR/CE SMN1/2 Plus Kit Provides SMN1 and SMN2 Copy Number Information and More

Asuragen 338

12:00 PM 12:50 PM Powerfully Fast and Suitable for any Lab – Fully-automated Molecular Testing with Idylla™ Biocartis 343

12:00 PM 12:50 PM Current and Emerging Biomarkers: Science, Technologies, and Practicalities Bristol Myers Squibb 341

12:00 PM 12:50 PM Advancements with Methylated cf-DNA Epigenomics, Inc. 339

12:00 PM 12:50 PM Comprehensive Genomic Profiling: Towards Precision Medicine Illumina 308

12:00 PM 12:50 PM

Emerging Biomarkers in Non-small Cell Lung Cancer (NSCLC) and Thyroid Cancer: A Pathologist Perspective on Why and How to Test for RET Alterations

Loxo Oncology 309

12:00 PM 12:50 PM Precision Medicine Powered by a Rapid, Flexible, and Scalable Target Enrichment Technology Paragon Genomics, Inc. 318-320

12:00 PM 12:50 PM Automated NGS Bioinformatics for Clinical Oncology – the PGDx elio™ Decentralized Model

Personal Genome Diagnostics 321-323

1:00 PM

1:00 PM 1:50 PMUsing Next-generation Sequencing to Establish Reference Samples for Benchmarking Cancer Mutations

ATCC 324-326

1:00 PM 1:50 PM

Bionano Genomics Saphyr: Enabling Comprehensive Assessment of Structural Rearrangements in Hematological and Solid Tumor Malignancies

Bionano Genomics 347-348

1:00 PM 1:50 PMMoving Beyond PD-L1 with RNA-based Multi-Analyte Models for Accurate Immune Profiling and Predictive Multidimensional Biomarkers

Cofactor Genomics 327-329

1:00 PM 1:50 PM Introducing the |Q|&A Platform. Digital PCR Re-imagined COMBiNATi 307

Page 8: AMP2019& EXPO ANNUAL MEETIN G...Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays Roche 327-329 10:00 AM 10:50 AM Scaling Molecular Laboratory

AMP 20196 | ANNIVERSARY CELEBRATION

ANNUAL MEETING & EXPO

AMP 2019 CORPORATE WORKSHOP DAY SCHEDULE AT A GLANCESTART END TITLE HOST ROOM

1:00 PM (CONTINUED)

1:00 PM 1:50 PMApplying Artificial Intelligence to Accelerate Variant Classification and Clinical Reporting of NGS Gene Panels

Fabric Genomics 345-346

1:00 PM 1:50 PMUsing Single-cell Genomics, AI, and Multi-omics to Unravel Treatment Resistant Mechanisms in Hematologic Malignancies and Solid Tumors

Mission Bio 342

1:00 PM 1:50 PMLab Experience – Performance Evaluation of QIAGEN’s GeneReader NGS System Workflow in Testing Complex Myeloid and Lung Cancer Samples

QIAGEN 316-317

1:00 PM 1:50 PM

Molecular Urinary Tract Pathogen Detection – The Value of Pairing Antimicrobial Susceptibility Testing Systems with Molecular Pathogen Detection: A Review of Clinical Research Studies

Thermo Fisher Scientific 314-315

1:00 PM 1:50 PM Twist Bioscience Corporate Workshop: Leading the Way in Target Enrichment Twist Bioscience 337

2:00 PM

2:00 PM 2:50 PMComparison of Manual Versus Automated NGS Library Preparation Using the New Magnis NGS Prep System and Cancer All-In-One Assay

Agilent Technologies 344

2:00 PM 2:50 PM Utilizing Archer NGS Assays for Detecting Heme Malignancies ArcherDx 343

2:00 PM 2:50 PM The Role of PARP Inhibition in Ovarian Cancer AstraZeneca 310

2:00 PM 2:50 PMNext-Generation Sequencing Within Your Reach: Complete, NGS-in-a-Box Testing Solutions for DNA and RNA Variants in Cancer

Asuragen 338

2:00 PM 2:50 PMOrthogonal Methods for Validation and Confirmation of Next Generation Sequencing (NGS) Results

Bio-Rad Laboratories, Inc. 341

2:00 PM 2:50 PM

A National Reference Laboratory Experience. Molecular Analysis of IGHV SHM in CLL/SLL Using LymphoTrack Assays, and the Clinical Utility of LeukoStrat CDx as an Adjunct to NGS Studies of AML

Invivoscribe 339

2:00 PM 2:50 PM

Implementation of the Karius® Test, a Quantitative Next-Generation Sequencing (NGS) Test, Which Identifies Microbial Cell-Free DNA from Plasma in Patients with Severe Infection

Karius 318-320

2:00 PM 2:50 PMThe PierianDx Clinical Genomics Knowledgebase: Removing the Interpretation Bottleneck Associated with Comprehensive Genomic Profiling

PierianDx 321-323

2:00 PM 2:50 PM Reducing Time for Clinical NGS Test Interpretation by 85% QIAGEN 316-317

2:00 PM 2:50 PM Navigating Reimbursement for Laboratory Developed Tests Thermo Fisher Scientific 314-315

2:00 PM 2:50 PMRecent Advances in Hydrazone-Based Bioconjugation Technology for Advanced Diagnostic and Therapeutic Applications

TriLink BioTechnologie 309

Page 9: AMP2019& EXPO ANNUAL MEETIN G...Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays Roche 327-329 10:00 AM 10:50 AM Scaling Molecular Laboratory

AMP 2019 ANNIVERSARY CELEBRATION | 7

ANNUAL MEETING & EXPO

AMP 2019 CORPORATE WORKSHOP DAY SCHEDULE AT A GLANCESTART END TITLE HOST ROOM

3:00 PM

3:00 PM 3:50 PMPathology Consultation: Incorporation of an NGS Minimal Residual Disease (MRD) Assay as a Standardized Approach for Disease Burden Assessme

Adaptive Biotechnologies Corp. 307

3:00 PM 3:50 PMLow Cost, High Sensitivity: The Advantages of MALDI-TOF for Liquid Biopsy and Solid Tumor Profiling

Agena Bioscience 337

3:00 PM 4:50 PM Optimizing Treatment Decisions in Lung Cancer: Refining the Biomarker Testing Approach AstraZeneca 310

3:00 PM 3:50 PM Detection of New and Emerging Biomarkers with Clinical Relevance in NSCLC using Blood-based ddPCR

Bio-Rad Laboratories, Inc. 341

3:00 PM 3:50 PM Pathology Leadership in Biomarker Testing: Pre-Analytical Phase Bristol Myers Squibb 340

3:00 PM 3:50 PM Supporting End-To-End Workflows in Clinical Genomic Laboratories Genosity 347-348

3:00 PM 3:50 PM Expediting the Path from Biomarker Discovery to Assay Commercialization

LGC, Biosearch Technologies 324-326

3:00 PM 3:50 PMThe Power of One: Simultaneous DNA Variant Profiling and RNA Fusion Detection in One Sample to Insight Workflow

QIAGEN 316-317

3:00 PM 3:50 PM Standardization of Molecular Monitoring for Chronic Myeloid Leukemia Patients Thermo Fisher Scientific 314-315

4:00 PM

4:00 PM 4:50 PM

Comprehensive Detection of Targetable Fusions in Lung Adenocarcinomas by Complementary Targeted DNAseq and RNAseq AssaysSpeaker: Dr. Ryma Benayed, MSK

ArcherDx 344

4:00 PM 4:50 PM

Mutational Signatures in Cytogenetics Risk Groups of Newly Diagnosed Acute Myeloid Leukemia. Presented by Robyn Sussman, PhD, Hospital of the University of Pennsylvania

Beckman Coulter Life Sciences 308

4:00 PM 4:50 PM

As a Leader in Quality Control, Bio-Rad Laboratories Presents a Review of Key US Regulations and Accreditation Requirements as it Relates to the Use of QC. Topics will include Validation, Verification, Daily QC, and Crossover Studies

Bio-Rad Laboratories, Inc. 341

4:00 PM 4:50 PM Validating and Implementing MGMT Promoter Methylation Testing in Clinical Laboratories EntroGen 321-323

4:00 PM 4:50 PMCell-free DNA Immunoglobulin Clonality Detection by LymphoTrack – A Liquid Biopsy Approach for B-cell Lymphoma

Invivoscribe 318-320

Page 10: AMP2019& EXPO ANNUAL MEETIN G...Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays Roche 327-329 10:00 AM 10:50 AM Scaling Molecular Laboratory

AMP 20198 | ANNIVERSARY CELEBRATION

ANNUAL MEETING & EXPO

AMP 2019 CORPORATE WORKSHOP DAY SCHEDULE AT A GLANCESTART END TITLE HOST ROOM

4:00 PM (CONTINUED)

4:00 PM 4:50 PM Carbapenem Resistance: Solutions for a Clear and Present Public Health Threat Meridian BioScience Inc. 342

4:00 PM 4:50 PM Technical and Workflow Considerations for NGS Applications from Cell-free Fluids PerkinElmer 338

4:00 PM 4:50 PMReagent Development at Commercial PCR Kit Provider and Cooperation Opportunities for Industry and OEM Partners

QIAGEN 316-317

4:00 PM 4:50 PM New Tools and Strategies for High Quality TMB Analysis by NGS

SeraCare Life Sciences, Inc. 309

Page 11: AMP2019& EXPO ANNUAL MEETIN G...Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays Roche 327-329 10:00 AM 10:50 AM Scaling Molecular Laboratory

AMP 2019 ANNIVERSARY CELEBRATION | 9

ANNUAL MEETING & EXPO

8:00 AM – 8:50 AMImplementation of Automated Comprehensive NGS Panel at a Community Cancer Center

Presented by: Dr. Qi Wei

Room: 318-320 Time: 08:00AM-08:50AM Hosted by: Beckman Coulter Life Sciences

Cancer is a disease of the genome. In the management of cancer patients, actionable mutations in cancer-associated genes are critical in the selection of therapies. Next-generation sequencing (NGS) of tumor samples DNA can guide clinical management by providing diagnostic and prognostics insight to facilitate the identification of potential treatment regiments, such as targeted and immune therapies. Here we present our experience on utilizing Biomek i5 to perform comprehensive NGS cancer panels (Illumina TruSight Tumor 170 and TruSight Oncology 500) in a community cancer center.

Easier and Faster BCR-ABL Monitoring with Cepheid’s Xpert BCR-ABL Ultra

Room: 344 Time: 08:00AM-08:50AM Hosted by: Cepheid

Traditional BCR-ABL monitoring for CML patients involves complex testing methodologies that are carried out by highly skilled technologists. The outcome is delayed time-to-result and inefficient use of technologist’s time. Cepheid’s Xpert BCR-ABL Ultra provides BCR-ABL monitoring results from whole blood in less than 3 hours. The simplified cartridge design enables labs to run individual samples with minimal hands-on-time and limits the risk of contamination. For easier, faster BCR-ABL monitoring, come learn more about the ultimate solution, Xpert BCR-ABL Ultra.

New Oncology Menu: Enhanced Capabilities to Enable Comprehensive Genomic Profiling

Room: 308 Time: 08:00AM-08:50AM Hosted by: Illumina

Join us to learn more about how the focus in oncology is enabling comprehensive genomic profiling (CGP).

Attend our workshop to understand the benefits of CGP and see our latest oncology portfolio updates.

Hyb & Seq™ Technology Based Rapid Pathogen Identification and Antibiotic Susceptibility Testing

Room: 339 Time: 08:00AM-08:50AM Hosted by: NanoString Technologies

Currently, the diagnosis of infection is often delayed, resulting in increased mortality. Rapid infectious disease diagnostics would transform the care of patients. This presentation highlights the ability of a novel hybridization based sequencing system, Hyb & SeqTM technology, and RNA signature based approach to allow a rapid universal pathogen identification and antibiotic susceptibility testing. Using a combination of genotypic and phenotypic information derived from a bacterial pathogen, we demonstrate the ability to provide clinically relevant data within the context of the necessary speed and sensitivity required for patient care.

Automated NGS Bioinformatics for Clinical Oncology – the PGDx elio™ Decentralized Model

Room: 321-323 Time: 08:00AM-08:50AM Hosted by: Personal Genome Diagnostics

Bioinformatics is a necessary component of NGS in clinical oncology, typically requiring trained experts to design and implement data filters and to manually curate mutation calls for accuracy. This necessary expertise and labor burden increases time to results, limits widespread accessibility of NGS for molecular pathology labs, and remains a significant barrier for new adopters. The PGDx elio™ decentralized NGS kits are designed as a system, integrating optimized chemistry with our proprietary automated bioinformatics platform, ensuring highly accurate results and rapid reporting. This approach is core to the PGDx elio™ decentralized model, increasing access for patients and bolstering clinical utility.

Page 12: AMP2019& EXPO ANNUAL MEETIN G...Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays Roche 327-329 10:00 AM 10:50 AM Scaling Molecular Laboratory

AMP 201910 | ANNIVERSARY CELEBRATION

ANNUAL MEETING & EXPO

Past, Present and Future Advances in MSI Testing

Room: 343 Time: 08:00AM-08:50AM Hosted by: Promega Corporation

With the recent discovery that cancers exhibiting microsatellite instability (MSI) are more likely to respond to certain types of immunotherapy, there is a growing need to develop reliable methods to determine MMR status for all cancers. This presentation will cover both basic and advanced topics for characterizing MSI status of tumor tissues and cell-free circulating tumor DNA from liquid biopsies using PCR-capillary electrophoresis, Next Generation Sequencing, and IHC approaches. The development and use of first, second, and third generation MSI analysis and associated technologies will be discussed.

From Raw Sample to Sequence-Ready Library: Fully Integrated and Automated Nucleic Acid Extraction and NGS Library Preparation Using the Rheonix NGS OnePrep™ Solution

Room: 338 Time: 08:00AM-08:50AM Hosted by: Rheonix, Inc.

Preparing NGS libraries for sequencing requires intensive manual labor and/or multiple instruments with multiple touchpoints to perform the separate processes of nucleic acid extraction and NGS library preparation. In this workshop, learn from industry experts about how they use the fully integrated and automated NGS OnePrep™ solution to obtain high quality NGS libraries directly from raw samples. Michael Buck, PhD, from the University at Buffalo’s NYS Center of Excellence in Bioinformatics and Life Sciences, and other speakers will share data and discuss the role of automated library prep in applications including microbiome and infectious disease.

Defining Your Lab’s Diagnostic Strategy for Improved Sexual Health Management

Room: 327-329 Time: 08:00AM-08:50AM Hosted by: Roche

Sexually transmitted infection (STI) rates in the U.S. are on the rise, leading to a significant cost burden on our healthcare system and serious long-term health consequences if left untreated. Emerging infections and the continued development of antibiotic resistance further complicate the STI landscape, presenting new challenges for clinicians, labs, and patients. While the introduction of new testing technologies brings the promise of better health outcomes, it can also pose challenges for the laboratorian trying to evaluate and understand the appropriate application for each new test. This presentation will address major trends impacting sexual health today and provide guidance on the role of the clinical laboratory in establishing a diagnostic strategy to help address evolving patient needs.

Technical and Regulatory Considerations for Designing Next-Generation Sequencing Controls and Standards for Optimal Quality and Performance: A Panel Discussion

Room: 09 Time: 08:00AM-08:50AM Hosted by: SeraCare Life Sciences, Inc.

Next-generation sequencing (NGS) has become the main technology for advanced molecular cancer diagnostics. Today, testing is expanding beyond laboratory-developed tests to companion diagnostics and manufactured gene-targeted IVDs. Developing kits and complete systems for highly multiplexed NGS assays requires special consideration for the design and manufacture of controls that meet regulatory requirements and provide rigorous quality assessments for each step in the NGS workflow. Hear invited panelists from industry, clinical labs, and a regulatory agency share their perspectives and experiences on the critical technical and regulatory issues around designing fit-for-purpose control materials for solid tumor and liquid biopsy IVD assays.

8:00 AM Continued

Page 13: AMP2019& EXPO ANNUAL MEETIN G...Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays Roche 327-329 10:00 AM 10:50 AM Scaling Molecular Laboratory

AMP 2019 ANNIVERSARY CELEBRATION | 11

ANNUAL MEETING & EXPO

9:00 AM – 9:50 AMPharmacogenetic (PGx) Sample Mischaracterization: The Prevalence and Impact of CYP2D6 Hybrid Alleles

Room: 337 Time: 09:00AM-09:50AM Hosted by: Agena Bioscience

CYP2D6 is one of the most important pharmacogenetic genes, being responsible for the metabolism and elimination of approximately 25% of clinically used drugs. It’s estimated that up to 45% of individuals possess a non-functional CYP2D6 hybrid allele. Common CYP2D6 genotyping and copy number variation detection methods cannot detect these alleles, resulting in pharmacogenetic profile mischaracterization. This session will provide an overview of CYP2D6 hybrid alleles, share studies showing their prevalence across populations and discuss the genetic characteristics that make their detection difficult. PGx experts will offer pragmatic recommendations for overcoming this unique challenge to provide a comprehensive CYP2D6 pharmacogenetic profile.

Rationale for Homologous Recombination Repair (HRR) Deficiency Testing in Select CancersSpeakers: Tabetha Sundin, PhD, HCLD, MB (ASCP)CM, Scientific Director Molecular Diagnostics and Serology, Sentara Healthcare

Room: 310 Time: 09:00AM-09:50AM Hosted by: AstraZeneca

This program:• Reviews the molecular biology of the Homologous Recombination Repair (HRR) pathway and how it relates to carcinogenesis • Explores the role of PARP inhibition in cancers with HRR mutations• Explains the rationale and methodology for BRCA and HRR testing• Reviews prevalence of HRR mutations and testing guidelines for select tumor types

Cancer Genomics at Scale to Improve Population Health: A Sonic Laboratories and Contextual Genomics Collaborative Approach

Room: 324-326 Time: 09:00AM-09:50AM Hosted by: Contextual Genomics

In the last decade several targeted therapies have been introduced for primary and secondary treatment of cancers. Yet, studies have shown that <10% of patients are being tested. Dr. Melissa McConechy, Sr. Manager of Contextual Genomics, will discuss how offering high-quality, affordable, NGS cancer assays for the assessment of relevant mutations has helped to increase accessibility to cancer patients in different markets. Additionally, she will describe a Canadian early access program for non-invasive ctDNA testing to increase accessibility throughout Canada.

New Oncology Menu for NovaSeq 6000 System: Offers Flexibility for High-throughput Testing of Liquid Biopsy and FFPE Samples

Room: 308 Time: 09:00AM-09:50AM Hosted by: Illumina

Molecular & Oncology healthcare professionals share how they navigate the challenges of the cancer care continuum.

IDT Complete Molecular Diagnostics Workflows

Room: 307 Time: 09:00AM-09:50AM Hosted by: Integrated DNA Technologies

Advances in NGS have rapidly transformed molecular diagnostics; however, 2 main challenges remain: conventional library preparation methods struggle with real-world samples, and personalized medicine requires custom tools. The next evolution of target capture, NGS Discovery Pools, offers the quality of individual synthesis at the speed, scale, and cost needed to develop assays for precision medicine. Our upcoming library preparation kit enables superior conversion for liquid biopsy and FFPE samples and incorporates error-correcting sequences for the highest level of accuracy. Combining advanced library prep and flexible capture panels, you have everything needed to overcome the most difficult molecular diagnostic challenges.

Page 14: AMP2019& EXPO ANNUAL MEETIN G...Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays Roche 327-329 10:00 AM 10:50 AM Scaling Molecular Laboratory

AMP 201912 | ANNIVERSARY CELEBRATION

ANNUAL MEETING & EXPO

Quantitative Analysis of Intracellular Signaling Pathways in FFPE Tumor Tissue

Room: 339 Time: 09:00AM-09:50AM Hosted by: NanoString Technologies

Next generation sequencing of DNA and RNA from tumor samples provides genomic information important for the clinical management of cancer patients, but the correlation with protein expression is imperfect and protein phosphorylation levels are not assessable by this approach. The Nanostring 3D Vantage Solid Tumor Panel is comprised of 27 antibodies, including 13 phosphorylated protein targets, specifically designed to interrogate the MAPK and PI3K/mTOR signaling pathways. This presentation will discuss validation of this panel for the evaluation of core biopsies of metastatic breast carcinoma, and illustrate how the panel can provide quantitative comparisons of pre- versus on-treatment biopsies.

Christopher Corless, MD, PhD ProfessorVice Chair, Research Chief Medical Officer, Knight Diagnostic Laboratories

Evaluation of DiaSorin Molecular Enterovirus (EV) and Cytomegalovirus (CMV) Primer Pairs in Laboratory Developed Test (LDT) Implementation on the Open, Random-Access NeuMoDx™ 288 Molecular System

Room: 340 Time: 9:00AM-9:50AM Hosted by: NeuMoDx

NeuMoDx Molecular offers scalable solutions integrating the molecular diagnostic process from sample to result for modern clinical laboratories. The NeuMoDx™ 96 and NeuMoDx™ 288 Molecular Systems are fully automated, continuous random-access analyzers that deliver enhanced performance with greater efficiency, and rapid turnaround times. In this workshop, Steve Young, Ph.D. Director of Research and Clinical Trials at TriCore Reference Laboratories will present results of implementing a qualitative EV LDT and a quantitative CMV LDT on the open, random-access NeuMoDx™ 288 Molecular System. Dr. Young will share TriCore’s experiences in implementing the assays and will review various performance characteristics of both assays.

Screening for Mismatch Repair Deficiency in the Era of Immunotherapy. A Single Institution Experience and Lessons Learned

Room: 343 Time: 09:00AM-09:50AM Hosted by: Promega Corporation

Following the approval of Pembrolizumab – and subsequently ipilimumab – for mismatch-repair deficient (dMMR) or microsatellite instability-high (MSI-H) tumors, the Department of Pathology and Columbia University Irving Medical Center adopted a policy of reflex testing of tumors for dMMR and MSI with oncologist input, selecting tumor types for testing at diagnosis, with testing of all metastatic/recurrent tumors. The talk will discuss our experience with testing over 2000 tumors with this approach, including the rationale for parallel testing, concordance of assays, logistical issues, and lessons learned. Illustrative examples will be presented.

The Dual Trend of Centralization and Decentralization: How Should Your Lab Adapt?

Room: 327-329 Time: 09:00AM-09:50AM Hosted by: Roche

Molecular testing has historically been a siloed endeavor, however, with the rise of platform consolidation some health systems are moving to a more centralized model of testing. At the same time, areas like point-of-care testing have spurred the growth of new distributed models. With the rise of automated testing solutions comes a greater need to anticipate the flow of samples, ensuring high efficiency. This topic will review how laboratories could take steps to adapt to the changing healthcare landscape, and how to evaluate which models will work best for their institution.

Expand Molecular Profiling in NSCLC for Existing and Emerging Biomarkers

Room: 314-315 Time: 09:00AM-09:50AM Hosted by: Thermo Fisher Scientific

During this workshop, speakers will review current biomarker and testing landscape. New biomarkers such as RET fusions will be discussed, along with their role in tumor pathogenesis, latest clinical research data, and pros and cons of different methods to detect aberrations from FFPE tissue samples.

9:00 AM Continued

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AMP 2019 ANNIVERSARY CELEBRATION | 13

ANNUAL MEETING & EXPO

10:00 AM – 10:50 AMSimple, Sensitive, and Scalable Patient Monitoring with the QuantideX® qPCR BCR-ABL IS Kit

Room: 338 Time: 10:00AM-10:50AM Hosted by: Asuragen

The emergence of new treatments and management approaches in chronic myeloid leukemia (CML) has generated long-term survival statistics that nearly mirror that of the general population. This longer-living and ever-growing patient population paired with the increased demand for detecting even deeper molecular responses now requires laboratories to implement a highly sensitive, scalable, and streamlined solution to keep up with increasing testing demands. In this workshop, we will review how the FDA-cleared, QuantideX® qPCR BCR-ABL IS Kit not only arms laboratories with a simple and easy-to-implement solution for BCR-ABL monitoring today, but prepares them for the demands and challenges of tomorrow.

Overcoming Challenges of MYB-NFIB Gene Fusion Detection from FFPE Adenoid Cystic Carcinoma Tissues Employing nCounter® Analysis; An Exploratory Study

Speaker: John B McIntyre, PhD

Room: 339 Time: 10:00AM-10:50AM Hosted by: NanoString Technologies

Adenoid cystic carcinoma (ACC) is a slow growing salivary gland malignancy that is molecularly characterized by t(6:9)(q22-23;p23-24) translocations, predominantly resulting in MYB-NFIB gene fusions. Detection of MYB-NFIB transcripts is typically performed with fresh tissue using RT-PCR fragment analysis or FISH, but fails frequently on FFPE tissue. nCounter technology with direct hybridization and counting of target molecules was evaluated for detecting MYB-NFIB fusions from FFPE. A probeset with three probes targeting annotated MYB-NFIB fusion genes and 5’/3’ MYB probes to detect unknown fusions were used to profile 25 FFPE ACC specimens. RT-qPCR and sequencing were performed to confirm NanoString results.

Development and Validation of a Novel Diagnostic Test for Non-Alcoholic Steatohepatitis (NASH)

Room: 343 Time: 10:00AM-10:50AM Hosted by: Promega Corporation

Approximately 25-30% of the global population has non-alcoholic fatty liver disease. Between 11-40% will progress to non-alcoholic steatohepatitis (NASH), where inflammation and fibrosis increase the risk of disease progression. Genfit’s “NIS4” test is a promising assay that identifies patients with moderate to advanced fibrosis who should be considered for NASH therapeutic clinical trials. NIS4 is an algorithm-based test that incorporates the values of four circulating markers. This workshop will highlight the miR-34a-5p assay, a major component of the NIS4 test and it will focus on Genfit’s assay development and its independent validation at Covance.

Syndromic Solutions to Aid Therapeutic Decision Making for Patients with Respiratory InfectionSpeaker: Dr. Glen Hansen

Room: 316-317 Time: 10:00AM-10:50AM Hosted by: QIAGEN

Evolution of Speed and Robustness – Mutated DNA Polymerases for the Modern Competitive Assays

Room: 327-329 Time: 10:00AM-10:50AM Hosted by: Roche

Modern development of PCR-based IVD assays require reliable results with shorter workflows. In particular, the point-of-care segment is focused on short time to result. However, several obstacles to accelerating the time to result exist such as enzymes inability to run fast cycling protocols, long sample preparation, and presence of inhibitors.

To help you overcome these issues, Roche CustomBiotech now offers low glycerol KAPA2G and glycerol-free KAPA3G DNA Polymerases developed for speed, high inhibitor tolerance, and for use in dried down assays. Join our workshop to learn more.

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AMP 201914 | ANNIVERSARY CELEBRATION

ANNUAL MEETING & EXPO

Scaling Molecular Laboratory Diagnostics for Volume, Efficiency, and Compliance

Room: 321-323 Time: 10:00AM-10:50AM Hosted by: Sunquest Information Systems

Scaling Molecular Laboratory Diagnostics for Volume, Efficiency, and Compliance with the advent of precision medicine, molecular labs are facing greater testing demand than ever before, particularly for highly-specialized, complex cancer testing Oncology diagnostics include molecular and genetic testing, which are marked by complicated steps, rapid pace of change, detailed regulatory auditing, and the use of multiple instruments. Learn how labs are streamlining molecular and genetic testing operations, scaling for volume and growth, and mastering compliance through the use of a cloud-based, configurable LIMS and genetic analysis software built specifically for the challenges of oncology diagnostics, next-generation sequencing, and precision medicine.

Workflow Solutions for Streamlining your Assays using Clinically-relevant Sample Types

Room: 309 Time: 10:00AM-10:50AM Hosted by: Takara Bio USA

Takara Bio USA will host a workshop on workflow solutions for clinically-relevant sample types. Topics will include isolation and handling FFPE and cell-free nucleic acids, and interrogation of these sample types using streamlined workflows for molecular techniques including next-generation sequencing (NGS), arrays, and qPCR. Data from the application of these workflows will be shared to show improvements in accessibility to clinically-relevant sample types in biomarker detection assays.

Latest Case Studies and Innovations in Solid Tumor Clinical Research for Targeted and Immuno-oncology Biomarkers

Room: 314-315 Time: 10:00AM-10:50AM Hosted by: Thermo Fisher Scientific

As the oncology biomarker landscape continues to evolve, greater clarity is needed in understanding the prevalence and proper utilization of targeted and immuno-oncology biomarkers in solid tumor evaluation. In this workshop, our first speaker will present best practices for utilization of tumor mutational burden (TMB). Our second speaker will discuss their evaluation and experience with TCR sequencing research solutions for solid tumors. Our final speaker will present new innovations that enable detection of microsatellite instability (MSI).

11:00 AM – 11:50 AMWorkshop Title: “Advancing Patient Care in Solid Tumors: Innovative Biomarker-based Approaches to Molecular Diagnostics”.

Room: 337 Time: 11:00AM-11:50PM Hosted by: Abbott Molecular

Workshop Description: Abbott Molecular Scientific Affairs invites you to an introduction to biomarker-based molecular technologies in clinical solid tumor research applications. Moderator: Yelina Noskina, Ph.D., Global Scientific Affairs Manager, Oncology, Abbott Molecular.

Enabling NGS-based Metagenomics in the Clinical Microbiology Laboratory

Room: 345-346 Time: 11:00AM-11:50AM Hosted by: Arc Bio LLC

Diagnostic microbiology has expanded rapidly in recent years, with metagenomic technologies now at the forefront of this expansion. Join us to listen to your peers discuss the unique challenges and opportunities that unbiased NGS-based metagenomics for pathogen detection offers.

A brief introduction to the Galileo™ Pathogen Solution platform* will be followed by a presentation from Professor Judith Breuer, MD FRCPath FMedSci, University College London/Great Ormond Street Hospital NHS Foundation Trust who will discuss the findings from her study using the Galileo™ Pathogen Solution for the detection and quantification of viral pathogens in pediatric immunocompromised patients, as well as sharing insights into the use of metagenomics for the diagnosis and management of patients.

*For Research Use Only. Not for use in diagnostics or diagnostic procedures.

10:00 AM Continued

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AMP 2019 ANNIVERSARY CELEBRATION | 15

ANNUAL MEETING & EXPO

Multiplexing Multiplied: How ChromaCode is Revolutionizing Multiplex Real-Time and Digital PCR Testing with Data Science

Room: 324-326 Time: 11:00AM-11:50AM Hosted by: ChromaCode

Data science uses statistics, machine learning, and related mathematical methods in order to understand phenomena with data. This field is drastically changing how industries approach problem-solving and value creation. ChromaCode is redefining diagnostics through data science. ChromaCode’s novel technology (HDPCR) enhances multiplexing levels of the most common qPCR and dPCR instruments for test applications of 5-50 targets. In this workshop, Dr. Michael Frumkin, Head of Accelerated Sciences at Google, will discuss applications of data science for healthcare and diagnostics. Following that, Dr. Blake Buchan, Medical College of Wisconsin, will discuss HDPCR applications for multiplex tick-borne pathogen and multi-drug resistance testing.

Finding Flexibility in a Resource Limited World: Considerations for Amplicon-based NGS Enrichment in Laboratories Running Multiple Sample and Assay Types

Room: 340 Time: 11:00AM-11:50PM Hosted by: Pillar Biosciences Inc.

While there are multiple advantages to implementing NGS in the clinical lab, NGS testing has the potential to be both time and resource consuming. Cynthia Schandl, MD, PhD and Julie Hirschhorn, PhD of the Medical University of South Carolina will discuss their process for selection of solid tumor and myeloid panels for evaluation. While keeping clinical relevance in mind, the selection process involved assessing assays for flexibility, affordability, and ease-of-use. This presentation will include an evaluation and discussion of the single-tube Stem-Loop Inhibition Mediated Amplification (SLIMamp®) technology from Pillar Biosciences for detection of variants in solid and myeloid tumors.

Rapid Molecular Testing for Influenza Using Solana

Room: 347-348 Time: 11:00AM-11:50AM Hosted by: Quidel Corporation

Influenza A and B epidemics cause significant morbidity and mortality especially among high-risk populations. Rapid and accurate diagnostic testing is essential for the timely management of these patients. Molecular testing offers great sensitivity and specificity when compared to other rapid influenza assays. Choosing the proper molecular platform is challenging and requires consideration of multiple factors including cost, volume of testing, turn-around-time, technical expertise and hands on time. We will be presenting the process and outcome that took place at our institution for the implementation of the Solana platform during the influenza season 2018-2019.

AVENIO ctDNA Clinical Research Story: Surveillance & Monitoring

Room: 327-329 Time: 11:00AM-11:50AM Hosted by: Roche

There are multiple challenges present in the disease monitoring of solid tumors; treatment options are available but broadly-applicable disease monitoring is not yet established. The AVENIO NGS Surveillance kit enabled by CAPP-Seq technology is proven to be feasible in ctDNA-based monitoring of lung and colorectal cancers, moving toward ctDNA-guided disease management. This workshop will discuss clinical research results using the AVENIO somatic oncology kits, minimal residual disease (MRD) detection through ctDNA analysis, disease monitoring starting with and without matched tissue biopsies, and future opportunities for AVENIO assays in clinical cancer research.

Increasing the Resolution of Molecular Cytogenetic Analyses through Cell Enrichment

Room: 307 Time: 11:00AM-11:50AM Hosted by: STEMCELL Technologies, Inc.

In hematologic cancers including lymphoid neoplasms, malignant and non-malignant cells are mixed in bone marrow or peripheral blood at variable frequencies. To detect abnormal clones by cytogenetic techniques such as FISH, it is necessary to analyze a large number of cells and rare malignant cells may be missed. Enrichment of lymphoid cells prior to FISH can enhance the sensitivity of this analysis by increasing the frequency of malignant cells in the analyte. Join Dr. Farzad Nooraie as he presents his experience on how cell enrichment impacts the resolution of FISH analysis in detecting chromosomal aberrations in B cell malignancies.

11:00 AM Continued

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AMP 201916 | ANNIVERSARY CELEBRATION

ANNUAL MEETING & EXPO

Next-generation Sequencing (NGS) in Hematology-oncology Clinical Research: From Initial Assessment to MRD

Room: 314-315 Time: 11:00AM-11:50AM Hosted by: Thermo Fisher Scientific

Rapid adoption of molecular approaches in hematology-oncology have significantly advanced our understanding of this highly heterogenous group of disorders. Recently, labs are turning to next-generation sequencing (NGS), which offers many advantages and efficiencies over conventional molecular techniques. In this workshop, speakers will present their evaluation of and experience with targeted NGS-based assays for the assessment of myeloid and lymphoid malignancies. Speakers will also review applications of BCR repertoire sequencing in B-cell malignancies and present their evaluation of new BCR assays for the assessment of somatic hypermutation in clinical research samples and clinical research relating to measurable residual disease (MRD).

12:00 PM – 12:50 PMImpact of Quality Processes for Staging and Biomarker Testing on Care of Patients with NSCLC

Speakers: David Feller-Kopman, MD, Director, Bronchoscopy and Interventional Pulmonology; Professor of Medicine, Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine | John Longshore, PhD, FACMG, Director, Molecular Pathology Laboratory, Atrium Health, Carolinas Pathology Group

Room: 310 Time: 12:00PM-12:50PM Hosted by: AstraZeneca

This program reviews the importance of accurate staging in patients with Stage III NSCLC, and reviews considerations for quality diagnostic and biomarker testing for patients with Stage IV NSCLC.

From Two Days to Four Hours: How the AmplideX® PCR/CE SMN1/2 Plus Kit Provides SMN1 and SMN2 Copy Number Information and More

Room: 338 Time: 12:00PM-12:50PM Hosted by: Asuragen

Spinal muscular atrophy (SMA) results from the homozygous loss of SMN1, and its severity is inversely correlated with the number of SMN2 copies. Sequence similarities between these two genes has challenged assay development and current on-market solutions have a multi-day workflow. In this workshop, we review how the AmplideX® PCR/CE SMN1/2 Plus Kit (RUO) provides SMN1 and SMN2 copy number in a simple, scalable, and streamlined workflow in less than four hours. In the same reaction, the assay also detects variants associated with gene duplication as well as milder disease phenotypes.

Powerfully Fast and Suitable for any Lab -Fully-automated Molecular Testing with Idylla™

Room: 343 Time: 12:00PM-12:50PM Hosted by: Biocartis

Turnaround time remains a major issue in molecular biomarker testing in oncology and laboratories constantly face the challenge to provide accurate results in a timely manner while managing operational expenses with fixed resources at the same time.

In this session, get firsthand perspectives from presenters on how Idylla™ can help streamline workflows and improve turnaround times in virtually any lab, no matter if you want to bring molecular testing in-house or complement your existing NGS workflow with an ultra-rapid solution for actionable mutations.

Current and Emerging Biomarkers: Science, Technologies, and PracticalitiesSpeaker: Jeffrey Gregg, MD

Room: 341 Time: 12:00PM-12:50PM Hosted by: Bristol Myers Squibb

Our keynote speaker will explore current and emerging predictive Immuno-Oncology biomarkers that may have the potential to change how cancer is treated through precision medicine.

11:00 AM Continued

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AMP 2019 ANNIVERSARY CELEBRATION | 17

ANNUAL MEETING & EXPO

Advancements with Methylated cf-DNA

Room: 339 Time: 12:00PM-12:50PM Hosted by: Epigenomics, Inc.

Epigenomics will be presenting on the advancements with methylated cf-DNA in the areas of early cancer detection. Content will include early work in cancer detection, effectiveness in patient segments, and comparative models.

Comprehensive Genomic Profiling: Towards Precision Medicine

Room: 308 Time: 12:00PM-12:50PM Hosted by: Illumina

When correctly implemented, NGS methods provide millions of individual observations that are representative of the genetic makeup of a sample. Hybridization capture of target genomic regions allows NGS to be used for comprehensive profiling of clinical oncology specimens.

This live activity intends to close knowledge and competence gaps regarding the use of comprehensive genomic profiling, allowing physicians to prescribe the most effective, targeted cancer treatments to patients based on the genomic information specific to their own cancer (precision medicine).

Emerging Biomarkers in Non-small Cell Lung Cancer (NSCLC) and Thyroid Cancer: A Pathologist Perspective on Why and How to Test for RET Alterations

Room: 309 Time: 12:00PM-12:50PM Hosted by: Loxo Oncology

Precision oncology is changing how we detect genomic alterations. Pathologists play a critical role in determining appropriate methods to identify clinically actionable biomarkers. This session focuses on RET alterations as key oncogenic drivers in NSCLC and thyroid cancers, the clinical context of gene fusions and activating point mutations and an overview of diagnostic methods to detect different RET alterations.

Precision Medicine Powered by a Rapid, Flexible, and Scalable Target Enrichment Technology

Room: 318-320 Time: 12:00PM-12:50PM Hosted by: Paragon Genomics, Inc.

Paragon Genomics’ CleanPlex technology is a rapid, flexible, and scalable target enrichment solution that allows a wide range of NGS assays to be easily and quickly developed to advance precision medicine. The technology feature a proprietary background cleaning chemistry that effectively removes nonspecific PCR products to enable ultra high multiplexing of target-specific primers. This workshop will feature speakers from Admera Health, RareCyte, and Paragon Genomics to showcase the use of CleanPlex NGS panels for pharmacogenomics profiling, circulating cancer cell (CTC) based liquid biopsy, and tumor mutational burden (TMB) assessment.

Automated NGS Bioinformatics for Clinical Oncology – the PGDx elio™ Decentralized Model

Room: 321-323 Time: 12:00PM-12:50PM Hosted by: Personal Genome Diagnostics

NGS in clinical oncology is predominantly limited to send-out services, which results in lengthy turnaround times and largely excludes the pathologist from the diagnostic process. Coupled with an automated bioinformatics pipeline, the PGDx elio™ assays will offer a decentralized approach as a kitted IVD product to facilitate widespread adoption of NGS in clinical oncology. Rigorously developed in both plasma and tissue, the PGDx elio™ assays will be fully validated to ensure high sensitivity and specificity. The PGDx elio™ model is readily designed for onsite implementation, offering an in-house NGS solution, engaging pathologists and oncologists in the local patient care ecosystem.

12:00 PM Continued

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AMP 201918 | ANNIVERSARY CELEBRATION

ANNUAL MEETING & EXPO

1:00 PM – 1:50 PMUsing Next-generation Sequencing to Establish Reference Samples for Benchmarking Cancer Mutations

Room: 324-326 Time: 1:00PM-1:50PM Hosted by: ATCC

Next-generation sequencing (NGS)-based diagnostics have transformed clinical oncology. Yet, the lack of well-characterized, community-validated reference materials has challenged the development and analysis of NGS results. To address this, the FDA-led Sequencing Quality Control Phase II (SEQC2) consortium came together to characterize a triple-negative breast cancer cell line and its B lymphocyte-derived normal cell line for use as a community resource. Here, whole-genome sequencing, multiple sequencing replicates, and orthogonal mutation detection bioinformatics pipelines were used to identify and characterize variants and mutations while minimizing potential workflow biases. The resulting reference materials will help facilitate assay development, qualification, validation, and proficiency testing.

Bionano Genomics Saphyr: Enabling Comprehensive Assessment of Structural Rearrangements in Hematological and Solid Tumor Malignancies

Room: 347-348 Time: 1:00PM-1:50PM Hosted by: Bionano Genomics

Bionano Genomics is transforming cancer cytogenomics by elucidating rearrangements, frequently missed by NGS and cytogenetic methods. Bionano’s novel nanochannel based technology directly images extremely long, labelled DNA molecules, providing unmatched sensitivity to detect structural variations (SVs) across the genome. Saphyr enables extremely high coverage depth, detecting any SV type with more than 90% sensitivity, present in as little as 5% allele fraction. Studies to be presented will focus on how Bionano’s Saphyr system could replace almost all karyotyping, FISH and CNV-microarrays. View agenda https://bionanogenomics.com/news/events/

Moving Beyond PD-L1 with RNA-based Multi-Analyte Models for Accurate Immune Profiling and Predictive Multidimensional Biomarkers

Room: 327-329 Time: 1:00PM-1:50PM Hosted by: Cofactor Genomics

The current bottleneck in immune-oncology and more broadly, precision medicine, lies in a dependency on legacy diagnostics built on single-analyte biomarkers. Multidimensional RNA models have emerged to break through this barrier and reveal the full scope of actionable disease complexity. More specifically, this workshop covers new advances to greatly improve the performance and utility of profiling the tumor microenvironment using multidimensional RNA models through Predictive Immune Modeling. We cover the status and implementation of the technology in the context of Cofactor’s ImmunoPrism assay/reagent kit, and present results of studies deriving immune composition from limiting FFPE clinical specimens.

Introducing the |Q|&A Platform. Digital PCR Re-imagined

Room: 307 Time: 1:00PM-1:50PM Hosted by: COMBiNATi

COMBiNATi believes simplicity shouldn’t require sacrificing robustness, quality or rigor – in fact, it should enable it. Our easy-to-use digital PCR platform offers absolute quantification to track disease-relevant biomarkers over time with high accuracy and precision. Comprised of a single instrument and a single consumable, the core microfluidic technology enables partitioning of samples with minimal waste. Combined with the ability to robustly reject false positives and easily adapt traditional qPCR assays, COMBiNATi aims to democratize digital PCR for researchers all over the world.

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AMP 2019 ANNIVERSARY CELEBRATION | 19

ANNUAL MEETING & EXPO

Applying Artificial Intelligence to Accelerate Variant Classification and Clinical Reporting of NGS Gene Panels

Room: 345-346 Time: 1:00PM-1:50PM Hosted by: Fabric Genomics

Francisco De La Vega, Chief Scientific Officer of Fabric, will present data from our new inference engine that leverages deep gene and variant annotation for highly accurate ACMG variant classification for gene panels: Fabric ACE. As a demonstration of the efficiency achieved with ACE in routine testing, Dr. De La Vega will present results of the analysis of a 52-gene inherited cancer panel from a cohort of 2,642 cancer patients of diverse histology, showing a reduction of manual classification greater than 90%. ACE is embedded into Fabric Enterprise for complete FASTQ-to-clinical report workflow and allows labs to accelerate accurate variant interpretation, classification, and clinical reporting down to minutes per case, enabling labs to score variants rapidly, reproducibly, cost-effectively and at scale.

Using Single-cell Genomics, AI, and Multi-omics to Unravel Treatment Resistant Mechanisms in Hematologic Malignancies and Solid Tumors

Room: 342 Time: 1:00PM-1:50PM Hosted by: Mission Bio

The average readout from conventional bulk sequencing misses the rare events and underlying genetic diversity within and across cell populations. To improve patient stratification, therapy selection, and disease monitoring, we need insights into clonal architecture and mutation co-occurrence within every single cell. The Tapestri Platform enables the sensitive and unambiguous identification of clonal architecture by measuring SNVs, indels, CNVs and LOH simultaneously in the same single cells and detects rare subclones that is not possible with bulk NGS measurements. Hear from translational researchers and pathology labs characterizing heterogeneity at the single-cell level to move precision medicine forward.

Lab Experience – Performance Evaluation of QIAGEN’s GeneReader NGS System Workflow in Testing Complex Myeloid and Lung Cancer Samples

Speakers: Dr. Ravindra Kolhe (Georgia Esoteric & Molecular Laboratory) & Prof Peter Wild (Universität Frankfurt Klinikum

Room: 316-317 Time: 1:00PM-1:50PM Hosted by: QIAGEN

Next-Generation Sequencing (NGS) is becoming widely used for biomarker detection in Myeloid leukemia and Lung cancer samples, allowing testing of multiple markers at the same time. We will explore how 2x pre-optimized assays on the GeneReader NGS system have allowed laboratories to detect and call challenging variants in Myeloid and Lung cancer. The QIAGEN GeneReader NGS System, using the QIAact Myeloid DNA UMI panel and a custom Lung cancer assay, offers a complete Sample to Insight solution including bioinformatics tailored and optimized for the panel’s analysis and reporting, using QCI Analyze and QCI Interpret for GeneReader.

The GeneReader NGS System is for research use only. Not for use in diagnostic procedures.

Molecular Urinary Tract Pathogen Detection - The Value of Pairing Antimicrobial Susceptibility Testing Systems with Molecular Pathogen Detection: A Review of Clinical Research Studies

Room: 314-315 Time: 1:00PM-1:50PM Hosted by: Thermo Fisher Scientific

Frequently, laboratories perform urinary tract pathogen detection via culture. This can take a long time to result while missing key pathogens. In this workshop, we will present data from multiple clinical research studies by Pathnostics. This includes a randomized prospective study performed using their Guidance UGx test, a real-time PCR solution powered by Thermo Fisher components demonstrating an increased uropathogen detection rate, in addition to a separate study examining the impact of the Guidance UGx test in hospital admissions with non-ambulatory subjects. Furthermore, we will review the Thermo Scientific Sensititre Automated Antimicrobial Sensitivity System for sensitivity analysis of urine.

1:00 PM Continued

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AMP 201920 | ANNIVERSARY CELEBRATION

ANNUAL MEETING & EXPO

Twist Bioscience Corporate Workshop: Leading the Way in Target Enrichment

Room: 337 Time: 1:00PM-1:50PM Hosted by: Twist Bioscience

Twist Bioscience uses its proprietary DNA synthesis platform to build target enrichment panels for researchers performing next-generation sequencing experiments and analysis. Due to the precision of these Twist capture probes, researchers are able to considerably improve the accuracy of the downstream sequencing analysis and perform fewer sequencing runs per sample without sacrificing performance, saving them time and money. During this workshop, presenters will discuss various applications and present data from their work using Twist NGS Target Enrichment Solutions.

2:00 PM – 2:50 PMComparison of Manual Versus Automated NGS Library Preparation Using the New Magnis NGS Prep System and Cancer All-In-One Assay

Room: 344 Time: 2:00PM-2:50PM Hosted by: Agilent Technologies

Lung cancer samples from the University of Chieti-Pescara in Italy were processed manually using the new Agilent SureSelect All-In-One lung assay. This targeted NGS assay analyzes a panel of 20 genes relevant to NSCLC. The assay detects translocations, CNVs, indels, and SNVs all with one enrichment. The same samples were then processed using the new Magnis NGS Prep System, fully automated NGS library preparation system. In this session, we will compare the performance of manual versus automated library preparation using clinical FFPE and plasma samples containing translocations in ALK, EGRF, ROS1, and other variants.

Utilizing Archer NGS Assays for Detecting Heme Malignancies

Room: 343 Time: 2:00PM-2:50PM Hosted by: ArcherDx

Speakers- Barbara Anderson, MS and Sarah Rapisardo, PhD from Duke University describe their group’s experience with Unique Molecular Identifiers (UMIs) and discuss their validation and implementation of the Archer® VariantPlex® Myeloid assay and a custom Archer FusionPlex® assay to detect known and novel fusions in hematological malignancies.

The Role of PARP Inhibition in Ovarian CancerSpeakers: Eugene P. Toy, MD, Chief of Obstetrics and Gynecology and Director of Gynecologic Oncology, Rochester General Hospital

Room: 310 Time: 2:00PM-2:50PM Hosted by: AstraZeneca

This program:• Reviews the link between molecular profiles and disease pathogenesis in ovarian cancer• Discusses the clinical significance of PARP inhibition in BRCA1 and/or BRCA2–mutated ovarian cancer• Discusses the increased importance of genetic testing in ovarian cancer

Next-Generation Sequencing Within Your Reach: Complete, NGS-in-a-Box Testing Solutions for DNA and RNA Variants in Cancer

Room: 338 Time: 2:00PM-2:50PM Hosted by: Asuragen

As our understanding of biomarker relevance continues to expand in somatic oncology, the need for broad yet timely detection of these variants has grown considerably. While next-generation sequencing has helped overcome many of the obstacles associated with single-marker, sequential testing, implementation of the technology has not been without its challenges. In this workshop, we will highlight how the QuantideX® NGS RNA Lung Cancer and Hotspot 21 Kits (RUO) enable the detection of both DNA and RNA-associated variants including SNVs, indels, fusions, splicing events, and more via streamlined testing workflows and automated results interpretation.

1:00 PM Continued

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AMP 2019 ANNIVERSARY CELEBRATION | 21

ANNUAL MEETING & EXPO

Orthogonal Methods for Validation and Confirmation of Next Generation Sequencing (NGS) Results

Room: 341 Time: 2:00PM-2:50PM Hosted by: Bio-Rad Laboratories, Inc.

Current guidelines provide detailed instructions to ensure the performance and quality of the pre-analytical, sequencing and bioinformatics steps of NGS. In this presentation, Lawrence Jennings from the NGS Analytical Validation Working Group, will focus on the various orthogonal methods necessary to validate and confirm individual results for both laboratory developed tests and FDA submissions for NGS panels. Droplet digital PCR (ddPCR) is emerging as a key technique utilized in this setting and the current and future applications of ddpcr will be highlighted.

A National Reference Laboratory Experience. Molecular Analysis of IGHV SHM in CLL/SLL Using LymphoTrack Assays, and the Clinical Utility of LeukoStrat CDx as an Adjunct to NGS Studies of AML

Room: 339 Time: 2:00PM-2:50PM Hosted by: Invivoscribe

Under-estimation of mutant to wild type allelic ratio for FLT3 ITD mutations is a challenge for NGS. Given the medical ramifications for AML risk stratification indicated by NCCN guidelines, there is an interest in case studies in which the LeukoStrat CDx clarified NGS results for FLT3 mutant to wild type allelic ratio.

Rearranged IGH/TCR gene sequences are biomarkers for immune repertoire analysis including B-/T-cell clonality assessment across lymphoid malignancies. For CLL, a common adult leukemia, IGHV SHM status is a critical biomarker. Capturing the extreme diversity of SHM, LymphoTrack NGS testing is a favored methodology for IGHV SHM biomarker studies.

Implementation of the Karius® Test, a Quantitative Next-Generation Sequencing (NGS) Test, Which Identifies Microbial Cell-Free DNA from Plasma in Patients with Severe Infection

Room: 318-320 Time: 2:00PM-2:50PM Hosted by: Karius

The Karius Test uses microbial cell-free DNA from bacteria, DNA viruses, fungi, and parasites to identify pathogens throughout the body. This workshop describes the considerations of implementing the analytically and clinically validated Karius Test into clinical practice. A review of clinical cases is included.

The PierianDx Clinical Genomics Knowledgebase: Removing the Interpretation Bottleneck Associated with Comprehensive Genomic Profiling

Room: 321-323 Time: 2:00PM-2:50PM Hosted by: PierianDx

With the growing number of FDA-approved biomarkers in oncology, many of which are site agnostic, an approach for comprehensive genomic profiling has emerged. While good news for patient care, pan-cancer profiling assays present a multitude of interpretation challenges for which many laboratories are sorely unprepared. In this informative workshop, we discuss the utility of comprehensive genomic profiling and propose a knowledge sharing and inferencing approach in use by the PierianDx clinical community.

2:00 PM Continued

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Reducing Time for Clinical NGS Test Interpretation by 85%]

Speakers: Tumor Mutation Burden: Challenges and opportunities of measuring and interpreting tumor mutational burden for patient care | Ravindra Kolhe, Augusta University; QCI for Oncology: Flexible and scalable variant interpretation and reporting solutions for somatic profiling and TMB assays | Beate Litzenburger, Global Product Manager

Room: 316-317 Time: 2:00PM-2:50PM Hosted by: QIAGEN

Clinical genetic testing labs are challenged to analyze and interpret oncology tests with rapidly updated scientific evidence, drug approvals and treatment guidelines in an efficient, thorough, manner.

We will present QCI Interpret, an evidence-driven clinical decision support software, and QCI Precision Insights powered by N-of-One, the on-demand expert interpretation services. QCI leverages trusted content from an expansive data collection of curated literature from more than 40 public and proprietary databases including real-world data from over 146,000 patient cases across 1,100 diseases. We will discuss how QCI supports a variety of cancer panels to deliver actionable information on detected variants and immunotherapy biomarkers.

Navigating Reimbursement for Laboratory Developed Tests

Room: 314-315 Time: 2:00PM-2:50PM Hosted by: Thermo Fisher Scientific

In the United States, laboratory developed tests have been critical in the growth of innovative testing areas such as personalized medicine, and keeping up with the changing face of new and complex disease testing. But who pays for these tests? And are they reimbursable? This workshop explores the ways in which clinical laboratories navigate the reimbursement landscape in the US to allow innovative clinical genetic tests to be ordered to healthcare professionals for their patients. Hear from reimbursement experts as they discuss ways in which LDTs are reimbursed, the challenges they face and how to overcome these.

Recent Advances in Hydrazone-Based Bioconjugation Technology for Advanced Diagnostic and Therapeutic Applications

Room: 309 Time: 2:00PM-2:50PM Hosted by: TriLink BioTechnologies

Bioconjugation plays a crucial role in the development of reagents for diagnostic and therapeutic applications. Susan Bane, Ph.D., Professor of Chemistry at Binghamton University, State University of New York will review recent advancements in hydrazone formation, including structural features in the coupling partners and novel catalysts that significantly accelerate these reactions and permit their use at neutral pH. The advantages of aromatic hydrazones as stable and quantifiable coupling agents will be discussed. Bioconjugation results using these newer methods will be highlighted, including the author’s work in boronic acid-enhanced hydrazine chemistry and detection of oxidative stress-induced cellular damage using hydrazines.

3:00 PM – 3:50 PMPathology Consultation: Incorporation of an NGS Minimal Residual Disease (MRD) Assay as a Standardized Approach for Disease Burden Assessment

Room: 307 Time: 3:00PM-3:50PM Hosted by: Adaptive Biotechnologies Corp.

The utilization of NGS technology to detect and quantify Minimal Residual Disease (MRD) is enabling advances in the assessment and management of patients with hematological malignancies. Clinicians increasingly view MRD as a critical tool to inform clinical decision-making; the selection of a sensitive, specific, and standardized MRD assay is becoming an important decision in which pathologists should play a central role.

In this workshop, Mohammad Hussaini, M.D., Hematopathology and Molecular Pathology, Moffitt Cancer Center will present a pathologist’s perspective on utilizing a standardized NGS platform for MRD assessment in hematological malignancies.

2:00 PM Continued

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Low Cost, High Sensitivity: The Advantages of MALDI-TOF for Liquid Biopsy and Solid Tumor Profiling

Room: 337 Time: 3:00PM-3:50PM Hosted by: Agena Bioscience

In this two-part seminar, Dr. Pierre-Jean Lamy, from Imagenome in Montpellier, France will first review the results of his liquid biopsy study, which entails a head-to-head comparison between Agena’s UltraSEEK liquid biopsy chemistry and the Roche Cobas EGFR v2 Mutation Test. Dr. Lamy will also present the correlation of tumor-matched plasma samples with UltraSEEK. The second half of the seminar will feature Dr. Eduardo Castro, from Baylor Scott & White, in Dallas, Texas. Here, Dr. Castro will discuss how he validated the iPLEX HS solid tumor profiling panels and outline the decision criteria that led to choosing the MALDI-TOF platform.

Optimizing Treatment Decisions in Lung Cancer: Refining the Biomarker Testing ApproachSpeakers: Dr. Jed Gorden, MD, FCCP, Director of Interventional Pulmonology, Director of Lung Research at Swedish Cancer Institute; Talk Title: Diagnosis and Staging: at the Root of the NSCLC Treatment Decision Tree | Dr. Charu Aggarwal, MD, MPH, Medical Oncologist, Leslye M. Heisler Assistant Professor for Lung Cancer Excellence at Penn Medicine; Talk Title: Liquid Biopsies in Lung Cancer: Current State of Affairs | Dr. Darren Wheeler, MD, West Regional Medical Director, Quest Diagnostics and AmeriPath; Talk Title: Advancing Management of NSCLC Through Complementary Use of Tissue- and Plasma-Based Testing: Role and Opportunities for Pathologists

Room: 310 Time: 3:00PM-4:50PM Hosted by: AstraZeneca

Optimal management of patients with metastatic NSCLC who have targetable mutations depends heavily on comprehensive biomarker testing results. New technological advances have enabled improved tissue acquisition and comprehensive NGS testing. Furthermore, effective communication among the various medical disciplines involved in patient care is essential for optimal testing and treatment decisions.

This workshop, led by a medical oncologist, an interventional pulmonologist, and a pathologist, will discuss the latest advances in tissue acquisition and utility of liquid biopsy at diagnosis, to illustrate the importance of coordinated care through a multidisciplinary approach to ensure the timely implementation of evolving testing and treatment guidelines.

Detection of New and Emerging Biomarkers with Clinical Relevance in NSCLC Using Blood-based ddPCR

Room: 341 Time: 3:00PM-3:50PM Hosted by: Bio-Rad Laboratories, Inc.

Abstract:The GeneStrat® Genomic Test currently includes variant-specific ddPCR testing for EGFR, KRAS, BRAF and the ROS, RET and ALK fusions in blood. In this report, Gary Pestano, Chief Development Officer from Biodesix, will provide an update on test concepts created using the new Expert Design ddPCR process. Specifically, studies regarding the detection of MSI, EGFR C797S and EGFR Uncommon Variants in blood will be described. Design considerations, early feasibility product development, and the post-launch performance of one such test for EGFR Uncommon Variants and clinical utility of EGFR C797S will be highlighted.

Pathology Leadership in Biomarker Testing: Pre-Analytical PhaseSpeaker: Tabetha Sundin, PhD, HCLD, MB

Room: 340 Time: 3:00PM-3:50PM Hosted by: Bristol Myers Squibb

Our keynote speaker will review the intricacies of the pre-analytical phase and explore variables that may impact the reliability of laboratory testing, including biomarker results.

3:00 PM Continued

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ANNUAL MEETING & EXPO

Supporting End-To-End Workflows in Clinical Genomic Laboratories

Room: 347-348 Time: 3:00PM-3:50PM Hosted by: Genosity

Speaker: Bob Daber, PhD – Genosity President & Chief Technology Officer

While NGS testing is becoming commonplace for clinical diagnostics and research, a high bar of entry remains for new adopters. Beyond sequencing equipment, additional work requirements exist for data analysis, interpretation, reporting, and regulatory compliance.

In this workshop, Dr. Daber will demonstrate Genosity’s integrated genomics platform, which supports end-to-end clinical NGS workflows. The Genosity platform reduces the challenges associated with bioinformatics through a comprehensive offering of analysis pipelines, and facilitates customizable report generation with an AMP/ACMG-classified variant interpretation knowledgebase.

Expediting the Path from Biomarker Discovery to Assay Commercialization

Room: 324-326 Time: 3:00PM-3:50PM Hosted by: LGC, Biosearch Technologies

From biomarker discovery to molecular diagnostics assay development, selecting the right partner for critical components at an early stage ensures a smooth transition through development to commercialization.

Dr. Yasser Riazalhosseini (McGill University) will discuss biomarker discovery in clear cell renal cell carcinoma (ccRCC) utilizing LGC, Biosearch Technologies’ NxSeq™ AmpFREE Kit, which proved instrumental in generating consistent results throughout the international cohort study.

Dr. Bob Kruimels will address Insilixa’s development of a disposable biochip, enabling multiplex low-cost molecular diagnostics of up to 1,024 analytes. Insilixa utilized Biosearch Technologies’ expertise in probe design and scale-up to commercialize their novel POC technology.

The Power of One: Simultaneous DNA Variant Profiling and RNA Fusion Detection in One Sample to Insight WorkflowSpeakers: Reinventing Targeted Sequencing with QIAseq Multimodal: A Sample to Insight solution for integrated DNA and RNA analysis from one sample using a single-day workflow | Dan Heard, Global Product Management; The Power of One: Development of a novel one day workflow for simultaneous high sensitivity analysis of DNA variants and RNA fusions from sample to sequencing | Jonathan M. Shaffer PhD, MBA, Associate Director, NGS Assay Technologies

Room: 316-317 Time: 3:00PM-3:50PM Hosted by: QIAGEN

Cancer is a highly complex disease and understanding the various alterations that together determine mechanisms of disease onset, progression, recurrence and response to treatment is not trivial. Currently, multimodal approaches are used to explore biomarker status using DNA variant profiling and RNA fusion information. Though the information derived enables a better understanding of the various mechanisms in play, having to perform separate workflows increases the overall cost of the study due to the number of instruments, reagents, consumables and resources needed. Furthermore, samples, especially those derived from tissues, are often of limited quantity and quality. Therefore, streamlined workflows optimized with low sample-input requirements are preferred to ensure the retention of samples for further downstream studies.

In this workshop, we present an innovative approach to biomarker analysis, enabling simultaneous extraction and NGS-based interrogation of DNA and RNA from a single sample in just one day. This approach not only reduces hands-on and overall turn-around time for combined DNA and RNA profiling but, more importantly, provides critical DNA and RNA information from a single sample, enabling confident assessment of allelic expression of variants for a complete profile of the underlying molecular signatures related to disease.

Standardization of Molecular Monitoring for Chronic Myeloid Leukemia Patients

Room: 314-315 Time: 3:00PM-3:50PM Hosted by: Thermo Fisher Scientific

By attending this workshop, attendees will learn how to institute BCR-ABL testing for CML patients and understand how standardized molecular monitoring contribute to better patient management. The speaker will also introduce utilizing the reference material in standardization of molecular monitoring and discuss results from a multi-site study.

3:00 PM Continued

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4:00 PM – 4:50 PMDr. Ryma Benayed, MSK – Comprehensive Detection of Targetable Fusions in Lung Adenocarcinomas by Complementary Targeted DNAseq and RNAseq Assays

Room: 344 Time: 4:00PM-4:50PM Hosted by: ArcherDx

Comprehensive detection of targetable kinase fusions in lung cancer patients is clinically critical but technically challenging. In our recent study, we have evaluated the incremental benefit of targeted RNAseq in the identification of gene fusions in 275 patients where no clear mitogenic driver alteration is found by DNAseq-based panel testing. Gene fusions or MET exon 14 skipping were detected in 14% of cases apparently driver-negative by previous DNAseq testing. 80% of the patients who received matched targeted therapy have achieved a clinical benefit. Among the driver-negative samples tested by RNASeq, those with low tumor mutation burden were significantly enriched for gene fusions.

Mutational Signatures in Cytogenetics Risk Groups of Newly Diagnosed Acute Myeloid Leukemia. Presented by Robyn Sussman, PhD, Hospital of the University of Pennsylvania

Room: 308 Time: 4:00PM-4:50PM Hosted by: Beckman Coulter Life Sciences

Cytogenetic studies and next-generation sequencing (NGS) are frequently performed as standard workup for acute myeloid leukemia (AML) but few studies have correlated these tests. Cytogenetics alone or the combination of cytogenetics and NGS can be used to stratify AML into risk categories, following guidelines by either the Medical Research Council (MRC) or European Leukemia Net (ELN). We have assessed 152 patients with de novo AML (dnAML) who had both cytogenetic and NGS testing performed on their diagnostic specimen.

As a Leader in Quality Control, Bio-Rad Laboratories Presents a Review of Key US Regulations and Accreditation Requirements as it Relates to the Use of QC. Topics will include Validation, Verification, Daily QC, and Crossover Studies.

Room: 341 Time: 4:00PM-4:50PM Hosted by: Bio-Rad Laboratories, Inc.

QC and your Lab

Validating and Implementing MGMT Promoter Methylation Testing in Clinical Laboratories

Room: 321-323 Time: 4:00PM-4:50PM Hosted by: EntroGen

MGMT promoter methylation is a valuable biomarker used to predict favorable outcomes in glioblastoma when treated with alkylating agents. Implementing routine testing for MGMT promoter methylation remains challenging due to differences in platforms, methodologies, and a lack of consensus for calculating the optimal cut-off between methylated and un-methylated samples. In this workshop, two respected molecular diagnostic professionals will highlight the differences between various MGMT methylation detection methods, as well as discuss 1) their validation process, 2) tips for establishing cut-off values, 3) assay performance & interpretation of results, and 4) overall evaluation of EntroGen’s MGMT Methylation Detection Kit.

Cell-free DNA Immunoglobulin Clonality Detection by LymphoTrack - A Liquid Biopsy Approach for B-cell Lymphoma

Room: 318-320 Time: 4:00PM-4:50PM Hosted by: Invivoscribe

As hematopathology progresses, novel techniques such as next-generation sequencing (NGS) are increasingly used for diagnosis, prognosis, and to monitor therapeutic response. NGS-based clonality testing has become an essential component of pathologic evaluation of hematolymphoid proliferations because it allows researchers to evaluate an evolving clonal landscape. NGS enables unparalleled sensitivity to detect disease earlier and the flexibility to evaluate cell free DNA and genomic DNA from peripheral blood, bone marrow and FFPE samples. NGS is likely to continue to replace outdated methods such as PCR and flow cytometry as it offers a high precision insights to optimize leukemia and lymphoma management.

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AMP 201926 | ANNIVERSARY CELEBRATION

ANNUAL MEETING & EXPO

Carbapenem Resistance: Solutions for a Clear and Present Public Health Threat

Room: 342 Time: 4:00PM-4:50PM Hosted by: Meridian BioScience Inc.

Organisms resistant to last-resort antibiotics including Carbapenems, represent a growing threat to public health across the globe. The CDC designated carbapenem resistant Enterobacteriaceae (CRE) an urgent threat and a “nightmare bacteria.” In the US, CRE causes an estimated 9,000 infections and 600 deaths yearly (CDC). Accurate detection of carbapenem-resistant organisms is challenging for clinical laboratories, key participants in antimicrobial stewardship programs (ASP) deployed to combat resistance. New molecular testing technologies will battle against resistance and offer groundbreaking opportunities to prevent and manage MDROs.

Technical and Workflow Considerations for NGS Applications from Cell-free Fluids

Room: 338 Time: 4:00PM-4:50PM Hosted by: PerkinElmer

cfDNA and cfRNA are attractive sample types for molecular pathology research. Reliable reagents, coupled with PerkinElmer® automation, greatly assists in developing a robust pipeline for labs exploring the many applications derived from these sample types. Of growing interest, microRNAs contain unique features that make them potentially useful as biomarkers.

Join us to hear learn how to improve the efficiency and reproducibility of your cfDNA and cfRNA workflows and discuss your needs today!

For research use only. Not for use in diagnostic procedures.

Reagent Development at Commercial PCR Kit Provider and Cooperation Opportunities for Industry and OEM PartnersSpeaker: Dirk Schacht, Associate Director Global Product Management, QIAGEN PCR Systems & Assays

Room: 316-317 Time: 4:00PM-4:50PM Hosted by: QIAGEN

QIAGEN is a leading provider of PCR solutions with proven experience in both the development of reagents and assays and optimizing production procedures of enzymes and kits. The ongoing relationship with third parties in custom and OEM business has created a range of opportunities and support options QIAGEN can offer from its own experience in kit and assay development. The speaker will describe QIAGEN’s approach to kit development and respective support options for OEM and custom business around RT- and PCR-enzymes, mastermix formulations or assay development and supply.

New Tools and Strategies for High Quality TMB Analysis by NGS

Room: 309 Time: 4:00PM-4:50PM Hosted by: SeraCare Life Sciences, Inc.

Tumor mutational burden (TMB) is an increasingly important clinical biomarker for emerging immuno-oncology (IO) therapeutics. Join us for a clinical laboratory’s perspective on validating targeted NGS panels to support IO clinical trial projects using the first of its kind, purpose-built TMB reference materials. We will discuss the challenges of accurately measuring TMB in blood and tissue, and the development and application of reference materials to ensure the quality, standardization, and harmonization of TMB measurement by NGS.

4:00 PM Continued

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NOTES

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NOTES

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November 17–21, 2020November 17Short Course Day

November 18Corporate Workshop Day

November 19–21Scientific Program

Vancouver Convention CentreVancouver, British Columbia, Canada

MARK YOUR CALENDAR!

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Join our workshops and presentations at AMP 2019 At Illumina, we continue to innovate our next-generation sequencing (NGS) solutions to enable labs to set a new standard in oncology.

Attend our events or visit us at booth 2341 to learn more.

Learn more at www.illumina.com/AMP

For Research Use Only. Not for use in diagnostic procedures.

© 2019 Illumina, Inc. All rights reserved. QB 8447

Corporate WorkshopsNew Oncology Menu: Enhanced Capabilities to enable Comprehensive Genomic Profiling

Wednesday, November 6 | 8 AM–8:50 AM Baltimore Convention Center, Room 308

SpeakersBiswajit Das, PhDPrincipal Scientist, Molecular Characterization and Clinical Assay Development Laboratory (MoCha), Frederick National Laboratory for Cancer Research, Frederick, MD

Stephanie Hastings, PhDStaff Scientist II, Assay Development Translational Genomics, Q2 Solutions

Stakeholders Perspectives on Molecular Medicine: A Panel Discussion

Wednesday, November 6 | 9 AM–9:50 AM Baltimore Convention Center, Room 308

PanelistsCarlo Bifulco, MDMedical Director of Oncologic Molecular Pathology and Pathology Informatics Providence St. Joseph Health 

Rachel Sanborn, MDCo-Director, Providence Thoracic Oncology Program Providence St. Joseph Health

Gabriel Bien-Willner, MD, PhDMoIDx Medical Director Palmetto GBA

Gregory J. Tsongalis, PhDProfessor of Pathology and Laboratory Medicine; Director, Clinical Genomics and Advanced Technology (CGAT) Theodor Geisel School of Medicine at Dartmouth

Innovation SpotlightsComprehensive Genomic Profiling Is Becoming a Standard of Care in Oncology

Thursday, November 7 | 3 PM–3:30 PM Exhibit Hall - Innovation Spotlight Stage

SpeakerPhil Febbo, MDSVP, Chief Medical Officer, Illumina

Enabling Comprehensive Genomic Profiling from FFPE & Liquid Biopsy Samples on a single High-Throughput Sequencing Platform

Friday, November 8 | 2:45 PM–3:15 PM Exhibit Hall - Innovation Spotlight Stage

SpeakersBrandon SelbySr Product Manager, Oncology, Illumina

Brandon Kocher, PhDSr Product Manager, Oncology, Illumina