FDA
FDA's recommendation that Alzheimer's patients be tested for APOE status prior to starting the drug could lead to new regulatory approvals and payor coverage.
FDA Approves Foundation Medicine CDx for Use With Janssen Drug in Prostate Cancer Patients
The test will be used as a companion diagnostic for patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer.
Experts Call for Better FDA Policing of Direct-to-Consumer Polygenic Risk Scores
In a commentary in the Journal of the American Medical Association, experts described health concerns related to direct-to-consumer polygenic risk score services.
Invivoscribe Gets FDA Approval for LeukoStrat CDx for Daiichi Sankyo Leukemia Drug
The PCR-based test detects internal tandem duplication and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.
The projects signal ongoing concern among health regulators about the quality and regulation of lab-developed tests used to guide cancer treatment and gauge disease risk.