webcast resource

Quality Standards for Clinical Genomic Tests and why this is important for health care

QA & QC from pre analytical steps to clinical utility

September 08, 2016 | Length: 29:37 min


Congress:Innovation and Biomarkers in Cancer Drug Development
Presenter:C. Vietz

Dr. Vietz (PhD, RAC) is Director of Quality Assurance at Foundation Medicine, Inc. She has over 14 years of experience in assay development and clinical diagnostics. Her expertise in assay development began with work as a scientist developing high-complexity tests for a CLIA certified laboratory and has progressed through operational management roles to her current position directing quality assurance and regulatory activities at Foundation Medicine. Dr. Vietz has a broad range of quality and regulatory experience including successfully leading several laboratories through CAP accreditation, obtaining NY approval of the Foundation Medicine tests (NGS-based comprehensive genomic profile for cancer), and most recently on Companion Diagnostic PMA and IDE submission work at Foundation Medicine.

Category: Cancer;