Thursday, September 10, 2015

FDA Announces NGS Public Policy Workshops on November 12,13, 2015

The FDA has announced public policy workshops on two aspects of next generation sequencing, to be held Thursday November 12 and Friday November 13.  (This was the only Friday the 13th available this year).

The November 12 session is: Standards-Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests.

The November 13 session is: Use of Databases for Establishing the Clinical Relevance of Human Genetic Variants.

UPDATE (October 22, 2015): FDA has updated the conference webpage with a Discussion Document on the use of databases for variants.  Here.
Terminology watchers will note that the FDA scrupulously refers to NGS "in vitro diagnostic tests," whereas other groups like the Association of Molecular Pathology are equally scrupulous in referring to NGS as "genomic sequencing procedures," e.g. the practice of medicine in the laboratory setting.

The FDA discussion of the workshops and their goals is here.
The November 12 announcement is here.
The November 13 announcement is here.  

The November 12 workshop homepage is here.
The November 13 workshop homepage is here.

For the November 13 workshop, attendee registration is by October 30 (assuming not sold out) and speaker registration by October 26.

Agendas have not been posted yet.  FDA will provide streaming video of both workshops.

Friends of Cancer Research has gotten a headstart on the November 13 FDA meeting, and published a "Blueprint for Genetic Databases" in the context of drug/diagnostic codevelopment.  FOCR workshop here, PDF of FOCR proposal, here (12 pages). FOCR writes,

o Proposal #1: Define the minimum core data elements required for the interpretation
of clinical significance of variants
o Proposal #2: Establish a framework to evaluate the strength of evidence for
genotype/phenotype associations
o Proposal #3: Determine the context of use of a database that encompasses
information outlined in proposal #1 and supported with the levels of evidence
captured in proposal #2
o Proposal #4: Incentivize data sharing into publicly available research- and regulatorygrade

These proposals are broad; the body of the document talks about strengths of particular associations such as mutation/drug response (e.g. mutation XYZ and Xalkori response).

Pink Sheet ran an article on genomics databases on September 21, 2015 (here).