PhenoPathDiagnoses you can count on®

Diagnoses you can count on®www.phenopath.com

henoPath provides anatomic pathology services for Phase I–III clinical trials. Our team adapts its service delivery to reflect your project design, management and implementation requirements.

PhenoPath is experienced in working with third-party vendors to ensure timely and trackable specimen management, either directly from sponsor sites or another CRO.

PhenoPath understands the need for timely results on entrance criteria testing, and provides rapid turnaround time for biomarker-testing assays. Board-certified pathologists and/or scientists evaluate all assays. Report formats are customizable to reflect either individual case or cumulative case formats.

PATHOLOGY SERVICES

DIAGNOSIS & INTERPRETATION• Solidtumordiagnosisandsubtyping,includingbreast,colon,lung,sarcoma,etc.• Hematopathologydiagnosisandsubtypingincluding,lymphoid,myeloid,plasmacelldisorders,etc.• Tissuebiomarkerquantification,includingflowcytometry,immunohistochemistry(IHC),immunofluorescence(IF),

cytogenetics,fluorescencein situhybridization(FISH),chromogenicin situhybridization(CISH),DNA/RNAin situhybridization(ISH),andpolymerasechainreaction(PCR)

• Tissuemacrodissectionfordownstreamassay(s)• Tissuemicroarrayconstruction• Over450testsavailable

EXPERT CONSULTATION• Consultationontherapeutictargetselectionandquantificationinthepre-clinicalsetting• Consultationonallpathology-relatedaspectsofclinicaltrialdesign,includingoptimizedtherapeutictargetquantification• Secondopinionconsultationoncomplexcases,includingclinicalcorrelation

CONTINUOUS EDUCATION• PhenoPathpathologistsfollowthelatestdevelopmentsincancerdiagnosisandtreatment• PhenoPathpathologistspublishextensivelyinscientificpeer-reviewedjournals• PhenoPathPathology Reference Guideavailable• PhenoPathpathologistsareavailabletopresenton-siteatinvestigatormeetings

ENTRANCE & ENROLLMENT

RAPID ENTRANCE CRITERIA SCREENING• Rapidpathologytestingandevaluationbyboard-certifiedpathologistsandscientists• Closecoordinationwitheachsponsor's clinicaltrialorganizers

REPORTING CAPABILITIES• Customreportformats• Scalableandconfigurableresultsreportingdatabase• Virtualpathologyreportingcapabilities• Secureandencrypteddatatransferandarchiving

SPECIMEN MANAGEMENT• End-to-endspecimenacquisitionandtracking• Rapid-turnaroundtimeforenrollmentcriteria

CLINICAL TRIALS

PD-L1 by IHC

PP

vNov2015

PhenoPathDiagnoses you can count on®

SOLID TUMOR PATHOLOGY HEMATOPATHOLOGY

Diagnosisandsubtyping(breast,colon,lung,sarcoma,etc.) IndolentBcellnon-Hodgkinlymphoma

Undifferentiatedmalignantneoplasms Prognosticandpredictivemarkers

Carcinomasofunknownprimarysite AggressiveBcellnon-Hodgkinlymphoma

Spindlecelltumors/sarcomasubtyping Tcellnon-Hodgkinlymphoma

Mesotheliomavs.adenocarcinoma Lymphoblasticleukemia/lymphoma

Small,blue,roundcelltumors Hodgkinlymphoma

Germcellneoplasms Plasmacellneoplasms

Skinandmucosalimmunofluorescencestudies Acutemyeloidleukemias

Chronicmyeloidneoplasms(MDS&MPN) Rarehematolymphoidneoplasms

Hydatidiformmoleevaluation Benignhematolymphoidproliferations

Amyloidsubtyping

• PhenoPathhasanindependent,on-siteQualityAssuranceUnit(QAU)withseveraldecadesofcombinedexperienceinCLIA,GLPandGCPenvironments

• ComprehensiveQualityManagementSystem,including:» AllprocessesgovernedbySOPs» Changecontrolprocess» Proceduresforpreventativeandcorrectiveactions(CAPA)» Qualitymetrics» Competencyassessmentsoftechnicalstaff

REGULATORY COMPLIANCE• CAPaccreditationforhigh-complexitytestingunderCLIA• LicensedlaboratoryinCA,FL,MD,NY*,RI,andWA(*subset of services)• StudiesperformedinaccordancewithGLP/GCP,asapplicable• ClinicalTrialactivitiesatPhenoPathwillbeconductedaccordingtoPhenoPath'sStandardOperatingProcedure(SOPs)and

thefollowing:» ICHGuidelineforGoodClinicalPractice(E6)» GoodClinicalLaboratoryPracticesasoutlinedintheWHO"GoodClinicalLaboratoryPracticesGuideline"» EuropeanMedicinesAgency(EMA)"ReflectionPaperforLaboratoriesthatPerformtheAnalysisorEvaluationofClinicalTrialSpecimens."

EXPERTISE

QUALITY

IMP3 by IHC

If you would like more information about PhenoPath's BioPharma services, please visit our web site at www.phenopath.com, contact any of our pathologists (888-927-4366), or contact your sales representative to request a quote.