Industry players, faced with vague communications from the agency, scramble to decipher regulatory expectations and criticize the agency for trying to control PGx knowledge.
While the FDA has expressed concerns about PGx testing, CEO Erik Hennings said the company has taken measures to limit the risk of consumer harm.
CPIC wants to issue guidelines for non-actionable genes, standardize PGx terms, and work with groups like ClinGen and ClinVar to expand use of its guidelines.
Organizations including Quest, J&J, Medecision, and the ACCP have formed the Get the Medications Right (GTMRx) Institute to promote PGx testing.
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.
The agency said the MediMap tests are in violation of Federal Food, Drug, and Cosmetic Act because they are intended, in part, for use in disease diagnosis.
Decipher — formerly GenomeDx Biosciences — will help Dendreon identify patients who are likely to respond to its prostate cancer therapy Provenge.