Exploring Industry Implications for Regulation of NGS Technologies
1 Hour Video | Christine Vietz, Foundation Medicine
Next generation sequencing technologies (NGS) are revolutionizing the advancement of diagnostic tests. These tests, however, pose regulatory challenges for the FDA. As a result of the surge in NGS development, the FDA has released a discussion paper on probable methods for demonstrating the analytical and clinical capabilities of NGS technologies and is requesting public comment. While multiple stakeholders including academia, government regulators and industry manufacturers all support future innovation through the use of NGS, the need for clear and well developed regulatory framework is necessary in order for the industry to move forward in the development and application of these tests.
- Review of challenges unique to NGS and how these may be addressed
- Comparison of available guidance on NGS
- How LDT guidance may also impact NGS regulatory framework
Participants that will find this webinar most beneficial will be those involved in diagnostic companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Quality Assurance
- Clinical Affairs
Dr. Vietz 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 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.