Public Workshop - Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests, November 12, 2015
The Food and Drug Administration (FDA) announced a public workshop entitled “Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests.” The purpose of this workshop was to obtain feedback on possible analytical standards and approaches to develop or build on existing standardization efforts in order to optimize FDA’s regulation of next-generation sequencing (NGS)-based in vitro diagnostic tests. Comments and suggestions generated through this workshop also guided the use of regulatory science to advance the further development of appropriate and relevant performance standards for evaluation of next generation sequencing in vitro diagnostic tests that produce results on variation in the human genome.
- Discussion Paper
- Additional Information to Facilitate Discussion on Analytical Standards Approaches
- Date, Time and Location
- Federal Register Notice
- Webcast
- Transcript
- Agenda
- Contact Us
Date, Time and Location
This meeting wase held November 12, 2015, beginning at 8:30 am–5:00 pm at the following location:
FDA White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (the Great Room)
Silver Spring, MD, 20993
- FDA Campus Information (Airports, Directions, Lodging Accommodations, Public Transportation, etc.)
Webcast
Transcript
Agenda
Time | Subject | Name |
|---|---|---|
| 7:30–8:30 AM | Security screening and Pre-registration Sign-in | |
| 8:30–8:35 AM | Welcome | |
| 8:35–8:45 AM | Opening Remarks | Robert Califf, MD Deputy Commissioner for Medical Products and Tobacco, FDA |
| 8:45–9:15 AM | Meeting goals and background / Roadmap for developing analytical standards | David Litwack / Zivana Tezak, FDA |
| 9:15–10:45 AM | Panel discussion: Standards-based approaches to analytical validation–A Spectrum from Design Concept Standards to Performance Standards | Moderator: Zivana Tezak, FDA Panelists: Birgit Funke, Harvard Partners; Jared Maguire, Counsyl; Geoff Otto, Foundation Medicine; John Pfeifer, Washington University School of Medicine; Arend Sidow, Stanford; Erasmus Schneider, Wadsworth / New York State Dept. of Health |
| 1:00–12:30 PM | Panel discussion: Developing analytical standards for NGS-based assays | Moderator: Adam Berger, FDA Panelists: Gil Alterovitz, MIT/Global Alliance for Genomics and Health; Deanna Church, Personalis; Lisa Kalman, CDC; Girish Putcha, Palmetto / MolDX; Catherine Rehder, Duke/ACMG; Karl Voelkerding, ARUP / CAP |
| 12:30–1:30 PM | Lunch break | |
| 1:30–3:00 PM | Panel discussion: Developing bioinformatics strategies and tools for evaluating NGS tests | Moderator: Sharon Liang, FDA Panelists: Sean Davis, NCI; Tina Hambuch, Illumina; Sean Hofherr, Children’s National Medical Center; Kevin Jacobs, 23andMe; Niall Lennon, Broad Institute; Narayanan Veeraraghavan, Baylor College of Medicine |
| 3:00–3:45 PM | PrecisionFDA: A cloud-based community platform for NGS assay evaluation and exploration | Taha Kass-Hout, FDA |
| 3:45–4:45 PM | Open Public Comment | |
| 4:45–5:00 PM | Summary and Wrap Up | Elizabeth Mansfield, FDA |
Contact Us
For questions regarding workshop content please contact:
Zivana Tezak, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, WO 66, Silver Spring, MD 20993, Tel. 301-796-6206, email: zivana.tezak@fda.hhs.gov.