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Public Meeting: Ultra High Throughput Sequencing for Clinical Diagnostic Applications - Approaches to Assess Analytical Validity

Posted May 19 2011 12:00am

The Food and Drug Administration (FDA) is announcing a public meeting Ultra High Throughput Sequencing for Clinical Diagnostic Applications - Approaches to Assess Analytical Validity.

The purpose of the meeting is to discuss challenges in assessing analytical performance for ultra high throughput genomic sequencing-based clinical applications.

Date, Time and Location

This meeting will be held June 23, 2011, beginning at 8:00 a.m. at the following location:

FDA White Oak Campus
10903 New Hampshire Ave
The Great Room (Room 1503), White Oak Conference Center, Bldg 31
Silver Spring, MD, 20903

This meeting will be webcast and registration will be required.

Requests to make an oral presentation must be submitted by June 9, 2011. The deadline for submitting written or electronic comments to be presented at this public meeting is June 9, 2011.

Regardless of attendance at the public meeting, interested persons may submit either electronic or written comments on any discussion topic(s) to the open docket. The deadline for submitting comments to the docket is July 25, 2011. Submit electronic comments to . Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Food and drinks will be available for purchase by participants during the meeting breaks. As an alternative, you are welcome to bring your own food & drink items.


Ultra high throughput genomic sequencing technologies are currently extensively used in research and are entering clinical diagnostic use; they are expected to bring transformative public health applications.  In order to effectively utilize new sequencing technologies for clinical applications, appropriate evaluation tools (e.g., standards, well established criteria) are needed to determine the accuracy of the results. Any regulatory strategy for clinical tests based on ultra high throughput genomic sequencing will benefit from novel and scientifically agreed-upon approaches to analytical validation. FDA is holding this public meeting to start discussion on approaches that can provide the most useful information in establishing safety and effectiveness of genomic sequencing technologies when used clinically.

This public meeting seeks input from academia, government, industry, and other stakeholders on validation methodologies, materials, and bioinformatics approaches needed to address unique analytical validation requirements of ultra high throughput sequencing based molecular diagnostics and confirm the sequencing quality and the accuracy of the tests. The ultimate goal is to accelerate and support the introduction of safe and effective innovative diagnostics in public health applications.


8:00-8:05 Welcome and Logistics
8:05-8:15 Opening Remarks
8:15-8:30 Background and Purpose of the Meeting
8:30-9:30 Overview of Ultra High Throughput Sequencing Technologies and Applications
9:30-9:45 Q & A
9:45-10:00 Break
10:00-12:00pm Panel Discussion: Technical performance
12:00-1:00pm Lunch
1:00-2:00pm Public comments
2:00-3:30pm Overview and Comparison of Different Bioinformatics Tools for Ultra High Throughput Sequencing Data
3:30-3:45pm Q & A
3:45-4:00pm Break
4:00-6:00pm Panel Discussion: Bioinformatics
6:00pm Adjourn

Registration to Attend the Workshop

If you wish to attend this Workshop, you must register by close of business on June 9, 2011.

Registration is free and will be on a first-come, first-served basis for this meeting. Early registration is recommended because seating and webcast ports are limited.

If you wish to make an oral presentation during any of the open comment session at the meeting you must indicate this at the time of registration. You should also identify which discussion topic you wish to address in your presentation and submit a brief statement that describes your experience and/or expertise relevant to your proposed presentation. FDA will do its best to accommodate requests to speak.

Please use either the In-Person Workshop Attendance registration form, or the Online Webcast Viewing registration form.

For information regarding registration and special accommodations, contact:

  • Susan Monahan
    Office of Communication, Education, and Radiation Programs
    Center for Devices and Radiological Health
    Food and Drug Administration
    10903 New Hampshire Avenue, Bldg 66
    Silver Spring, MD 20993
    Phone: 301-796-5661

For information regarding the program, contact:

  • Zivana Tezak
    Center for Devices and Radiological Health
    Food and Drug Administration
    10903 New Hampshire Avenue, Bldg 66
    Silver Spring, MD 20993
    Phone: 301-796-6206
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