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Abbott Molecular ( formerly Vysis ) and CLL. John Proffitt September 21, 2006. 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 Molecular ( formerly Vysis ) and CLL


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    1. Abbott Molecular (formerly Vysis) and CLL John Proffitt September 21, 2006

    2. 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?

    3. Abbott Molecular Overview

    4. Our Foundation Abbott Vysis Celera Abbott Molecular

    5. New Molecular Facility • 140 Million in Sales • 500 Employees • Dedicated Molecular Facility • Research • Quality • Manufacturing • Molecular Sales, Service and Support Des Plaines, Illinois

    6. Abbott Molecular FocusUnmet Medical Needs Constitutional Genetic Testing Oncology Transplantation Genomics Discovery Innovation Through Automation Infectious Disease

    7. Infectious Disease RealTime PCR ASR • HBV** • HCV Quant** • HCVGenotype** • HSV1,2* • CMV** • EBV** • Enterovirus* • Parvovirus** • VZV** IVD • HIV-1 • HCV • CT/NG Sequencing IVD • ViroSeq * Future Launches ** Analyte Specific Reagent

    8. 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

    9. Deletions & Trisomy in CLL Compare SS LOCI w/ Vysis 13q14 deletion +12q13 p53 deletion 11q22deletion • CLL • Most common adult leukemia • Highly variable clinical course • Detection by cytogenetics unsatisfactory • Emerging variety of therapeutic options P53>11q>12q>13q Dohner, H, et al. NEJM, Vol. 343, No. 26, 2000

    10. CLL Two probe mixture p53/ATM Normal Normal 2O2G p53 Deletion ATM Deletion Abnormal 1O2G Abnormal 2O1G

    11. Three probe Mixture:D13S319(q14), LAMP1, CEP12 CLL Trisomy 12 Normal Abnormal 2O3G2A Normal 2O2G2A Trisomy 12 & del(13q14) Abnormal 1O3G2A

    12. 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

    13. P53/ATM/MYB(optional) D13S319/LAMP1/CEP12 IGH/CCND1 XT P53/CEP17 ATM/ CEP11 D13S319/ LAMP1 MDM2/ CEP12 MYB/ CEP6 CCND1/IGH XT Mayo & Vysis Set Comparison & Question • 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?

    14. 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

    15. Other Abbott CLL Activities

    16. 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

    17. DNA Methylation Assay • Novel Method from Rubicon Genomics • Involves PCR and WGA (Whole Genome Amplification) • WMA (Whole Methylome Amplification) • Not Currently Focused on CLL

    18. Automation CGH Microarray Technologies ** Next Generation Fully Automated System * **In Development *For Research Use Only

    19. Denaturation & Hybridization New! Slide Pre-treatment & Washing Slide Scanning & Enumeration VP2000 ThermoBrite Pre-treatment, Washing, Denaturation, Hybridization & Final Coverslip AutoVysion Xmatrx* 0 Automation Choices ThermoBrite Specimen Received *In Development

    20. 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.