abbott molecular ( formerly vysis ) and cll john proffitt september 21, 2006
TRANSCRIPT
Abbott Molecular (formerly Vysis) and CLL
John Proffitt September 21, 2006
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Abbott Molecular and CLL
Brief Overview of Abbott Molecular
Current CLL Related Products
CLL Related Products in Development
Other Abbott CLL Activities
What are CRC Study Needs?
Abbott Molecular Overview
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Abbott
Abbott Molecular
Vysis Celera
Our Foundation
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Des Plaines, Illinois
140 Million in Sales140 Million in Sales 500 Employees500 Employees Dedicated Molecular FacilityDedicated Molecular Facility
ResearchResearch
Quality Quality
ManufacturingManufacturing
Molecular Sales, Service Molecular Sales, Service and Support and Support
New Molecular Facility
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Infectious Disease
TransplantationConstitutional
Genetic Testing
Innovation
Through
Automation
Genomics
Discovery
Abbott Molecular FocusUnmet Medical Needs
Oncology
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ASR
HBV**
HCV Quant**
HCVGenotype**
HSV1,2*
CMV**
EBV**
Enterovirus*
Parvovirus**
VZV**
Infectious Disease
IVD
HIV-1
HCV
CT/NG
* Future Launches** Analyte Specific Reagent
IVD ViroSeq
RealTime PCR
Sequencing
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Current CLL Related Probes
Mixes
• P53 orange/ATM green (can add aqua MYB)
• D13S319 orange/LSI 9q34(LAMP1)aqua/CEP12 green
• IGH/CCND1 XT (mantle cell lymphoma)
Individual Probes
• P53 orange
• ATM orange
• MYB aqua
• D13S319 orange
• LSI 9q34(LAMP1) green
• CEP12 orange & green
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Deletions & Trisomy in CLL Compare SS LOCI w/ Vysis
CLL
• Most common adult leukemia
• Highly variable clinical course
• Detection by cytogenetics unsatisfactory
• Emerging variety of therapeutic options
Dohner, H, et al. NEJM, Vol. 343, No. 26, 2000Dohner, H, et al. NEJM, Vol. 343, No. 26, 2000
11q22deletion11q22deletion
p53 deletionp53 deletion
+12q13 +12q13
13q14 deletion13q14 deletion
P53>11q>12q>13q
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Normal
ATM Deletion p53 Deletion
CLL
Normal 2O2G
Abnormal 2O1G Abnormal 1O2G
Two probe mixture p53/ATM
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Trisomy 12
Three probe Mixture: D13S319(q14), LAMP1, CEP12
Trisomy 12 & del(13q14)
CLL
Normal 2O2G2A Abnormal 2O3G2A
Abnormal 1O3G2A
Normal
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Mayo Probe Set Requested by G. Dewald for CRC
P53 orange/CEP17 green
ATM orange/ CEP11 green
D13S319 orange/ LAMP1(LSI 9q34) green
MDM2 orange/ CEP12 green
MYB orange/ CEP6 green
CCND1 orange/IGH green XT
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Mayo & Vysis Set Comparison & Question
•P53/ATM/MYB(optional)
•D13S319/LAMP1/CEP12
•IGH/CCND1 XT
P53/CEP17
ATM/ CEP11
D13S319/ LAMP1
MDM2/ CEP12
MYB/ CEP6
CCND1/IGH XT•3 hybs vs. 6 hybs•7-8 vs. 12 probes•What data supports 12 probe mix superiority?•Will CRC study generate the needed data?•Is 6q marker needed?•Is MYB 6q23 superior to 6q21/other?•MDM2(12q15) vs. 12q13(CHOP,CDK4,GLI) orCEP12?•ATM vs. FDX/RDX?
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Mayo Set; Current Status at Vysis
P53/CEP17: Ready for External Testing; Sale~ 1/18
ATM/CEP11: Assay Optimization; Sale~ 2/5
D13S319/LAMP1: Assay Optimization; Sale ~1/18
MDM2/CEP12: External Testing, CLL & Liposarcoma, Sale~11/23
MYB/CEP6: Bulk Probes Made, Market, CRC?
CCND1/IGH XT: Existing Product
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Other Abbott CLL Activities
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Targeting the unmet medical need: the Abbott Laboratories oncology approach.Clin Adv Hematol Oncol. 2005 Sep;3(9):703-10.
Endothelin A-receptor antagonist atrasentan/Xinlay
Angiogenesis inhibitors ABT 510, a thrombospondin mimetic:
ABT 869, a multitargeted receptor tyrosine kinase inhibitor
ABT 828, recombinant human plasminogen kringle 5
Cell proliferation inhibitor/antimitotic agent ABT 751
Multitargeted receptor tyrosine kinase inhibitor ABT 869
Apoptosis inducer/Bcl-2 family inhibitor ABT 737
Monotherapy efficacy in xenograft models of small-cell lung cancer and lymphoma. Affinity for bcl-2, Bcl-XL & Bcl-w 100-1000x greater than other other cmpds. Nature. 2005 Jun 2;435(7042):677-81
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DNA Methylation Assay
Novel Method from Rubicon Genomics
Involves PCR and WGA (Whole Genome Amplification)
WMA (Whole Methylome Amplification)
Not Currently Focused on CLL
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CGH Microarray Technologies
Next Generation Fully Automated
System
Automation
*
*For Research Use Only **In Development
**
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Automation Choices
SpecimenReceived
ThermoBrite
SlidePre-treatment
& Washing
VP2000
Denaturation &
Hybridization
Slide Scanning& Enumeration
AutoVysion
ThermoBrite
New!
Xmatrx*
Pre-treatment, Washing,
Denaturation,Hybridization &Final Coverslip
*In Development
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What Are CRC Study Plans & Probe Needs?
What are the studies/what goals?
What probes?
Are loci fixed or do some need investigation?
When are the probes needed?
What quantities of probes?
How to distribute?
Is a single entity able to bind all institutions in an agreement?
•Like to avoid multiple agreements w/ multiple sites.