Genomadix Gets FDA 510(k) Clearance for PCR System, CYP2C19 Test
Canada's Genomadix, formerly known as Spartan Bioscience, expects to now commercialize the system and test in the US to guide therapy decisions.
Patients in Florida and New Jersey can request a $199 video consultation with a pharmacist to interpret pharmacogenetic test results from approved labs.
The three-year Ubiquitous Pharmacogenomics Consortium's PREPARE study enrolled nearly 7,000 patients in seven European countries.
Doctors will be able to test patients for 17 genes known to influence response to 62 drugs and receive guidance from EHR-embedded pre- and post-test alerts.
Proove Biosciences CEO Exonerated in PGx Test Kickback Case
Proove's founder and CEO was indicted last year on charges the company had defrauded Medicare and violated the Anti-Kickback Statute by paying physicians to use its pharmacogenetic tests.