News on companion diagnostics and drug/test co-development.
Guardant Health Secures New Commercial Payor Coverage for Liquid Biopsy Cancer Profiling Test
With new coverage from Anthem Blue Cross and Blue Shield, Aetna, and Humana, the firm's Guardant360/Guardant360 CDx assay is now covered by all major commercial health insurers.
Invivoscribe Leukemia CDx Assay Nabs IVDR Approval
The PCR-based test detects internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene in patients with acute myelogenous leukemia.
Servier Nets Tibsovo Approvals in EU for IDH1-Mutant Bile Duct Cancer, AML
European regulators approved these indications based on data from the ClarIDHy trial in bile duct cancer and AGILE trial in AML.
Bayer, Telix Pharmaceuticals Partner to Study Nubeqa in Hormone-Sensitive Prostate Cancer
Telix will supply its PSMA imaging agent Illuccix, which Bayer will use to determine if patients have at least one PSMA-positive prostate cancer lesion at baseline.
FoundationOne Liquid Biopsy Assay Gets FDA OK as Companion Diagnostic for Takeda's Exkivity
Foundation Medicine said its assay is the only blood-based comprehensive genomic profiling platform to have gained this approval for Takeda's EGFR drug.