Medical Devices

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.

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







7:30–8:30 AMSecurity screening and Pre-registration Sign-in 
8:30–8:35 AMWelcome 
8:35–8:45 AMOpening RemarksRobert Califf, MD
Deputy Commissioner for Medical Products and Tobacco, FDA
8:45–9:15 AMMeeting goals and background / Roadmap for developing analytical standardsDavid Litwack / Zivana Tezak, FDA
9:15–10:45 AMPanel 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 PMPanel discussion: Developing analytical standards for NGS-based assaysModerator: 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 PMLunch break 
1:30–3:00 PMPanel discussion: Developing bioinformatics strategies and tools for evaluating NGS testsModerator: Sharon Liang, FDA

PanelistsSean 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 PMPrecisionFDA: A cloud-based community platform for NGS assay evaluation and exploration Taha Kass-Hout, FDA
3:45–4:45 PMOpen Public Comment 
4:45–5:00 PMSummary and Wrap UpElizabeth 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:

Page Last Updated: 12/21/2015
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