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.
At the Precision Medicine World Conference, researchers from Sanford Health, Providence Health, and Israel's Maccabi discussed their genomics programs.
A study of the detection of potential adverse drug events or interactions found that using PGx information led to better prediction of serious issues, despite no significant change overall.
The test covers 27 genes in which variants are known to contribute to the effectiveness or safety of more than 360 medications for 30 conditions.
At a Thermo Fisher-sponsored workshop, two companies argued for the clinical utility of PGx LDTs as FDA prepared to issue a warning against unapproved tests.
The system relies on the use of scannable safety code cards containing patient data, along with a web portal and automated analysis tools that deliver customized diagnostic reports.