regulatory approval
Guardant Health Liquid Biopsy CDx Gets Japanese Regulatory Approval for Janssen Lung Cancer Drug
Patients with inoperable or recurrent NSCLC and EGFR exon 20 insertion mutations may be eligible for Janssen Pharmaceutical's amivantamab-vmjw.
Adaptive Biotechnologies Gets IVDR Class C Certification for ClonoSeq Assay
The certification makes the ClonoSeq assay available to EU patients and enables Adaptive to process EU clinical trial samples in its US laboratory.
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.