New NGS Guidances for Laboratory Developed Tests (LDT): FDA’s Liz Mansfield on Audio Podcast

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New NGS Guidances for Laboratory Developed Tests (LDT): FDA’s Liz Mansfield on Audio Podcast

July 19, 2016 by 2012pharmaceutical

New NGS Guidances for Laboratory Developed Tests (LDT): FDA’s Liz Mansfield on Audio Podcast

Reporter: Aviva Lev-Ari, PhD, RN

FDA’s Liz Mansfield on New NGS Guidances

Submitted by Ayanna Monteverdi on Tue, 07/19/2016 – 09:18

AUDIO PODCAST

Liz Mansfield Show 2016.mp3

Liz Mansfield, Deputy Office Director for Personalized Medicine at the FDA

Chapters:

0:00 A boss who gets it

1:53 The unique challenge of regulating NGS

7:00 How does the new guidance relate to the recent LDT guidance?

12:02 “We’d like to finalize the LDT guidance.”

On July 6th, as part of the President’s Precision Medicine Initiative, the FDA issued two new draft guidances for the oversight of next gen sequencing (NGS) tests. The first guidance is for using NGS testing to diagnose germline diseases. In the second, the FDA lists guidelines for building and using genetic variant databases.

To help us understand just what the guidance is and what led to its release, we’re joined by Liz Mansfield, the Deputy Office Director for Personalized Medicine at the FDA.

It’s unusual for the FDA to issue guidance around a single technology, but Liz says that NGS is “transformative” and is eclipsing so many of the older technologies. The biggest challenge is that NGS is a technology used for discovery and has the power to test for so many things at once.

How does the new NGS guidance relate to the much talked about guidance on LDTs that came out a couple years ago? And does the new guidance represent a more incremental, step by step approach for the FDA in dealing with the explosion of today’s molecular testing field?

“No, it’s not an attempt to break down into smaller bites the issue on LDTs. It’s to address this particular technology, regardless of who the developer is,” says Liz.

The two guidances are for very specific purposes and Liz anticipates further NGS guidances to be issued in the future. For example, guidelines for dealing with somatic mutations rather than germline mutations.

Here is a link to the new FDA Guidelines:

Click to access ucm509837.pdf

Use of Public Human Genetic Variant 2 Databases to Support Clinical Validity 3 for Next Generation Sequencing 4 (NGS)-Based In Vitro Diagnostics

AND

Click to access ucm509838.pdf

Use of Standards in FDA Regulatory 2 Oversight of Next Generation 3 Sequencing (NGS)-Based In Vitro 4 Diagnostics (IVDs) Used for 5 Diagnosing Germline Diseases

SOURCE

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Date: Tuesday, July 19, 2016 at 12:00 PM

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: FDA’s Liz Mansfield on New NGS Guidances