With 10,000 of Mayo's patients now sequenced for 77 genes, a subset of this information is being used to inform care while the bulk of the data is spurring research projects.
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.
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.
Two patients fell ill, and one subsequently died, following a fecal microbiome transplant that harbored multi-drug-resistant bacteria, according to the New York Times.
