pharmacogenetics
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.
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.
FDA Updates Xeloda Labeling to Make DPYD Variant Risks More Explicit
In response to a citizen petition, the FDA has added more specific language about testing patients for DPYD gene variants that place them at risk for severe treatment-related toxicities.
Genetika+ Snags CE Mark for Major Depressive Disorder Drug-Matching Test
The NeuroKaire test predicts a patient's drug response by combining patient-reported information, pharmacogenetics data, and so-called "brain-in-a-dish" functional testing.
The myPGx panel adds pharmacogenomics testing services from Veritas Genetics, a company the firm acquired earlier this year, to LetsGetChecked's portfolio.