Biodesix, a leading diagnostics solutions company, has announced an expanded partnership with Bio-Rad Laboratories to develop, clinically validate, and support regulatory submissions for in vitro diagnostic (IVD) assays designed for highly sensitive detection of multiple genomic markers in oncology. The collaboration will leverage Bio-Rad’s Droplet Digital™ PCR (ddPCR™) technology on its QX600 platform.
Following regulatory clearance, Biodesix will take charge of manufacturing and distributing dedicated specimen collection kits for the developed assays. The first test to undergo validation under this agreement is Bio-Rad’s ddPLEX ESR1 Mutation Detection Assay, which targets mutations in the ESR1 gene—an increasingly critical biomarker in HR+/HER2- advanced breast cancer. The test enables highly sensitive detection and absolute quantification of multiple ESR1 mutations from circulating tumor DNA (ctDNA), supporting precision treatment decisions.
Once validated, the ESR1 assay will be made available as a test service at Biodesix’s CLIA-CAP accredited laboratory, serving both biopharma clients in therapeutic development and clinical customers for cancer treatment monitoring. The company also plans to seek reimbursement approval from the Centers for Medicare & Medicaid Services (CMS) for the assay.
“The emergence of ESR1 mutations as biomarkers for breast cancer has had a significant impact on the oncology market, leading to an increased global demand for rapid, sensitive assays,” said Scott Hutton, CEO, Biodesix. “We are proud to expand our partnership with Bio-Rad through this new agreement, demonstrating how our combined capabilities in mutation detection can address clinical needs with speed and precision, and opening doors to personalized, data-driven medicine.”
“Through our long-standing relationship with Biodesix we have effectively delivered both clinical and research-based applications of our ddPCR technology for non-small cell lung cancer, as part of its Lung Diagnostics portfolio,” commented Steve Kulisch, VP Product Management, Life Science Group, Bio-Rad Laboratories. “Validation of our ddPLEX ESR1 kits will further expand our combined capabilities in clinical diagnostics, increasing access to sensitive biomarker detection for advanced breast cancer.”
