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A Brave New World In V itro Diagnostics Felice Shieh, PhD Senior Medical Science Liaison Genoptix , Inc.

A Brave New World In V itro Diagnostics Felice Shieh, PhD Senior Medical Science Liaison Genoptix , Inc. Agenda. Objectives. Understand the meaning of a diagnostic and its role in patient treatment algorithm Understand the current diagnostic landscape

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A Brave New World In V itro Diagnostics Felice Shieh, PhD Senior Medical Science Liaison Genoptix , Inc.

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  1. A Brave New WorldIn Vitro DiagnosticsFelice Shieh, PhDSenior Medical Science LiaisonGenoptix, Inc.

  2. Agenda

  3. Objectives • Understand the meaning of a diagnostic and its role in patient treatment algorithm • Understand the current diagnostic landscape • Understand where to find resources and information on diagnostics

  4. Definitions and Common Terminology • Diagnostic – test used to identify a possible disease or disorder • Companion Diagnostic - test to preselect patients for specific treatments • In Vitro Diagnostic - medical devices/biological products are regulated by set standards/codes • Research Use Only – not for use to make clinical decisions • Laboratory Developed Test – test developed within individual lab setting, can be used for clinical decisions

  5. In Vitro Diagnostic Process/Timeline Regular process ~137 days

  6. Real World Example of CDx Co-Approval Cheng et al, New Biotech 2011 ~5 years from development to FDA approval

  7. Common Types of Diagnostics • Molecular diagnostic – use of genomic or proteomic expressions/variants • Immunodiagnostic – use of antigen-antibody reaction • Symptomatic diagnostic – use of signs, indications, clinical characteristics • Radiological diagnostic – use of imaging technologies • Point of care – medical testing at or near site of patient • Direct to customer – commercially available to consumer testing

  8. Diagnostics and Patient TreatmentMelanoma Example

  9. Common Diagnostic Methods Protein Dx - immunoassay Molecular Dx - PCR AND MANY MORE… Karyotyping Cytogenetics Sequencing

  10. Current Diagnostic Landscape • $44 billion globally in 2011 • CAGR of 7.8% • U.S. represents ~ 47% • Molecular diagnostic is largest growing segment http://www.marketsandmarkets.com/Market-Reports/in-vitro-diagnostics-ivd-market-547.html

  11. Current Diagnostic LandscapeMolecular Dx Applications Molecular Dx >$4.8 Billion in 2011 @ CAGR of 9.1% http://www.prweb.com/releases/Molecular/diagnostics/prweb10179525.htm

  12. Current Molecular Diagnostic AssaysExamples of high-impact assays approved Brock, American Lab 2012

  13. Current Companion Diagnostic LandscapeExamples of approved CDx and Drug Brock, American Lab 2012

  14. Who are the key players in the field? Vysis - crizotinib cobas BRAF test - vemurafenib RGQ KRAS test - cetuximab

  15. What are the main challenges? • Establishing clinical utility • Clinical validation • IVD vs LDT and the FDA • Interpretation of results • Regulatory • Reimbursement

  16. What resources can you use to find more information? • Searchable database of FDA-approved or FDA-cleared assays: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm • FDA IVD general information- http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/default.htm • FDA IVD Regulation– • http://www.fda.gov/medicaldevices/deviceregulationandguidance/ivdregulatoryassistance/ucm123682.htm#1 • Market Research – Frost and Sullivan, LEK, Research and Markets • Guidelines – NCCN, ASCO, ACOG, CAP • Good sources for updates – Genome Web, CAP Today

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