Though the test is already commercially available, the firm met with the FDA last year to discuss plans for a randomized controlled trial to support regulatory approval.
How labs — including those that are part of other healthcare systems — offering PGx testing will react to Inova's decision to not engage with the FDA remains to be seen.
Pharmacogenetics and legal experts took particular issue with the agency's suggestion that "established" drug/gene relationships are found only in FDA-approved drug labels.
The program is supported via a $25 million gift from philanthropist Denny Sanford and matching contributions fundraised by Sanford Health.
Data from the GUIDED study will be central to commercial payor discussions, a Medicare LCD reconsideration request, and eventually expansion into the primary care market.
The genetic testing community is having a tough time deciphering FDA's intentions based on its authorization of 23andMe’s PGx test and a recent safety alert.
The agency informed the public that most PGx tests haven’t been reviewed by the agency, and they should refer to information in FDA approved product labels when using such tests.
The market authorization came with a number of caveats and special requirements that 23andMe must follow when selling its PGx tests to consumers.
The partners are advancing a comprehensive report on how the detected PGx markers impact drug response and customized reports focusing on specific types of drugs.
The funding will help the consortium continue creating and updating PGx guidelines, adding drug-gene pairings, and creating electronic tables that can be integrated within EHRs.