Biodesix announces expanded partnership to develop Droplet Digital™ PCR High Complexity Assays
Biodesix will perform the clinical validation of ddPLEX ESR1 Mutation Detection Assay for advanced breast cancer testing
30 Oct 2025
Biodesix, Inc. has announced the signing of an expanded partnership agreement under which Biodesix will conduct the development, clinical validation, and regulatory submissions of in vitro diagnostic (IVD) assays to enable highly sensitive detection of multiple genomic markers focused on oncology applications, utilizing Bio-Rad’s Droplet Digital™ PCR (ddPCR™) technology on Bio-Rad’s QX600 platform.
Following regulatory clearance, Biodesix will manufacture and distribute dedicated specimen collection kits for the developed assays.
The first assays to be validated under the agreement include Bio-Rad’s ddPLEX ESR1 Mutation Detection Assay. ESR1 testing is becoming critical in HR+/HER2- advanced breast cancer due to the clinically demonstrated survival benefits from a new generation of therapy called oral selective estrogen receptor degraders (SERDs).
The ddPLEX ESR1 Mutation assay will enable highly sensitive detection and absolute quantification of multiple ESR1 mutations from ctDNA samples.
Once validated, the ESR1 assay will be offered as a test service at Biodesix’s accredited CLIA-CAP laboratory for biopharma customers to support the development of targeted therapeutics, as well as for clinical customers to support cancer treatment monitoring. Biodesix will also seek reimbursement for this assay through Centers for Medicare & Medicaid Services (CMS).
“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.”