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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 WorldIn Vitro DiagnosticsFelice Shieh, PhDSenior Medical Science LiaisonGenoptix, Inc.
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
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
In Vitro Diagnostic Process/Timeline Regular process ~137 days
Real World Example of CDx Co-Approval Cheng et al, New Biotech 2011 ~5 years from development to FDA approval
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
Common Diagnostic Methods Protein Dx - immunoassay Molecular Dx - PCR AND MANY MORE… Karyotyping Cytogenetics Sequencing
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
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
Current Molecular Diagnostic AssaysExamples of high-impact assays approved Brock, American Lab 2012
Current Companion Diagnostic LandscapeExamples of approved CDx and Drug Brock, American Lab 2012
Who are the key players in the field? Vysis - crizotinib cobas BRAF test - vemurafenib RGQ KRAS test - cetuximab
What are the main challenges? • Establishing clinical utility • Clinical validation • IVD vs LDT and the FDA • Interpretation of results • Regulatory • Reimbursement
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