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.
While large health systems develop comprehensive precision medicine strategies, smaller hospitals don't want to wait for pharmacogenomics technology.
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.
The company's lead product is a software platform that uses a patient's pharmacogenetic and other medical data to help personalize drug selection.
Freshly minted as a "unicorn," the Utah healthcare data analytics powerhouse is building up a new life sciences division to aid biotech development and precision medicine.
Emedgene, which makes AI-based, automated genomic interpretation software, will use the Series A funding to expand its US sales operations.
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.
Bloomberg reports that the DNA-for-cash deal reported in Kentucky might be a more widespread scam.
St. Jude Children's Research Hospital scientists have treated infants with X-linked severe combined immunodeficiency using gene therapy in an early phase study.
St. Louis Public Radio reports that some African Americans are turning to DNA ancestry testing to help guide genealogical searches.
In Nature this week: a genomic analysis of the snailfish Pseudoliparis swirei, ancient DNA analysis gives insight into the introduction of farming to England, and more.