Biodesix Inc. is partnering with Bio-Rad Laboratories to develop, clinically validate, and eventually commercialize in-vitro diagnostic (IVD) assays that can detect multiple genomic markers (primarily focused on oncology applications) using 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 pair’s formal partnership 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.

“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,” Biodesix CEO Scott Hutton stated. “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.”

Once validated, the ESR1 assay will be offered as a test service at Biodesix’ 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).

“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, vice president of Product Management, Life Science Group, at 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.”

Biodesix is a diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests, marketed as Nodify Lung Nodule Risk Assessment and IQLung Cancer Treatment Guidance, support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s life sciences and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics.