Amoy Diagnostics HRD Kit Receives EU IVDR Certification

Amoy Diagnostics announced on September 15 that its independently developed AmoyDxHRD Complete Panel has received certification under the In Vitro Diagnostic Medical Devices Regulation from the EU notified body TUV SUD. It can be used as a companion diagnostic product to help identify patients with metastatic castration-resistant prostate cancer (mCRPC) who carry BRCA1/2 gene mutations, assisting in the selection of patients who have previously received treatment including novel hormonal agents and whose disease has progressed, and who may be suitable for olaparib monotherapy.