regulatory approval
Castle Biosciences Gains New York State Approval for Pittsburgh Laboratory
The company can now serve NY state patients from either of its two facilities, in addition to populations across other US states under its existing CLIA certifications.
Guardant Health Receives Guardant360 CDx Regulatory Approval in Japan for HER2 Lung Cancer Treatment
Patients who test positive for a HER2 mutation and have seen their disease progress after chemotherapy can now be treated with Daiichi Sankyo's Enhertu.
Amoy Diagnostics PLC Panel Gets Approval in Japan as CDx for Retevmo in Non-Small Cell Lung Cancer
Oncologists in Japan can now use the AmoyDx Pan Lung Cancer PCR Panel to identify patients with RET fusions that make them eligible for treatment with the Eli Lilly drug.
Prenetics' ACT Genomics Profiling Test for Solid Tumors Receives FDA Clearance
The regulatory clearance of ACTOnco comes on the heels of Prenetics' acquisition of a majority stake of ACT Genomics last month.
FDA Approves Foundation Medicine Blood Test as CDx for Rozlytrek
FoundationOne Liquid CDx, a liquid biopsy test, is the only blood-based CDx approved for the targeted cancer therapy.