Medical Devices

Public Workshop - Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests Public Workshop, February 20, 2015

The Food and Drug Administration (FDA) announced a public Workshop entitled: “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests.” The purpose of this workshop was to discuss and receive feedback from the community on FDA’s regulatory approach to diagnostic tests for human genetics or genomics using Next Generation Sequencing (NGS) technology.

Date, Time and Location

This meeting was held February 20, 2015, from 8:30 am to 5:00 pm. at the following location:

Natcher Center at the NIH Campus
9000 Rockville Pike
Bldg. 45, Auditorium
Bethesda, MD 20814

Presentation and Transcript



7:30–8:30Security Screening and Registration
8:35–8:40Opening remarksMargaret Hamburg, MD
Commissioner, FDA
8:40–8:45Precision Medicine InitiativeJo Handelsman, PhD
Associate Director for Science
White House Office of Science and Technology Policy
8:45–9:15Consideration of new regulatory approachesDavid Litwack, Ph.D.
Office of In Vitro Diagnostics and Radiological Health, FDA
Session 1 - Analytical Performance of NGS Tests
9:15–10:15Panel 1 - Developing analytical and process standardsModerator: Zivana Tezak (FDA)
Ben Neale (Broad Institute)
Deanna Church (Personalis)
John Pfeiffer (Washington University School of Medicine)
Christine Eng (Baylor College of Medicine)
Steve Lincoln (InVitae)
Mickey Williams (Frederick National Laboratory)
10:30–11:30Panel 2 - Implementing analytical and process standardsModerator: Liz Mansfield (FDA)
Marc Salit (NIST)
Karl Voelkerding (ARUP, College of American Pathologists)
Girish Putcha (Palmetto)
Ellen Sigal (Friends of Cancer Research)
Barbara Zehnbauer (CDC)
Victor Velculescu (Johns Hopkins University School of Medicine)
11:35–12:00 Public comment
11:36–11:40Felix Frueh, Human Longevity
11:41–11:45Bill Kurani, Agilent Technologies
11:51–11:55Federico Monzon, Invitae
11:56–12:00Benjamin Yu, Interpreta
Session 2 - Clinical Performance of NGS Tests
1:00–2:00Panel 3 - Use of evidence and database curationModerator: Eunice Lee (FDA)
Levi Garraway (Dana Farber Cancer Institute)
Heidi Rehm (Harvard Partners)
Gary Cutting (Johns Hopkins University School of Medicine)
Roman Yelensky (Foundation Medicine)
Jason Merker (Stanford School of Medicine)
Lou Stadt (NCI)
2:00–3:00Panel 4 - Communication of evidenceModerator: David Litwack (FDA)
Sherri Bale (GeneDx)
Len Lichtenfeld (American Cancer Society)
Sharon Terry (Genetic Alliance)
Robert Penny (Paradigm)
Don Hadley (NHGRI)
Section 3 - Regulatory Considerations
3:20–4:20Panel 5 - Factors in considering the optimal regulatory approach for NGSModerator: Katherine Donigan (FDA)
Donna Messner (Center for Medical Technology Policy)
Madhuri Hegde (Emory University School of Medicine)
Mya Thomae (Illumina)
Neil Risch (UCSF, ASHG)
Carl Gordon (Orbimed)
Laura Koontz (Ovarian Cancer National Alliance)
4:20–5:15Public Comments
4:26–4:30Anna  Longwell, Longwell and Associates
4:31–4:35Roger Klein, Association of Molecular Pathologists
4:36–4:40Sherri Bale, GeneDx
4:41–4:45David Flannery, American College of Medical Genetics and Genomics
4:46–4:50Jimmy Lin, NCI
4:51–4:55Karl Voelkerding, College of American Pathologists
4:56–5:00Deborah Smith, Blue Cross Blue Shield Association
5:01–5:05Deepak Ahuja, Quibble Genomics Institute
5:06–5:10Lisa Schlager, FORCE
5:11–5:15Dandan Xu, SolveBio
5:15–5:20Summary and Next Steps

Contact Us

For questions regarding workshop content please contact:
David Litwack, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, rm. 5544, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6697, email:

Page Last Updated: 03/25/2015
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