pharmacogenetics
Association for Molecular Pathology Releases CYP3A4 and CYP3A5 Genotyping Recommendations
The AMP Pharmacogenetics Working Group recommended four alleles for a minimum panel (tier 1) and one allele for an extended panel (tier 2).
UnitedHealthcare Wins $128M Fraud Lawsuit Against Texas Clinical Labs
A US District Court ruled in favor of UHC, which in 2017 sued clinical lab Next Health, alleging it had paid bribes for lab testing and billed for tests not performed.
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.