The agreement focuses on clinical validation of ESR1 mutation detection assay for advanced breast cancer testing using ddPCR technology.
Biodesix Inc has signed an expanded partnership agreement with Bio-Rad Laboratories to develop, clinically validate, and submit regulatory applications for in vitro diagnostic assays using Bio-Rad’s Droplet Digital PCR technology on the QX600 platform.
The collaboration will focus on highly sensitive detection of multiple genomic markers for oncology applications. Following regulatory clearance, Biodesix will manufacture and distribute dedicated specimen collection kits for the developed assays.
The initial 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 clinically demonstrated survival benefits from 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.
Laboratory Services and Reimbursement Plans
Once validated, the ESR1 assay will be offered as a test service at Biodesix’s accredited CLIA-CAP laboratory for biopharma customers to support targeted therapeutics development and for clinical customers to support cancer treatment monitoring. Biodesix will also seek reimbursement for this assay through the Centers for Medicare & Medicaid Services.
“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,” says Scott Hutton, CEO, Biodesix, in a release. “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.”
The partnership builds on the companies’ existing relationship in delivering clinical and research-based applications of ddPCR technology for non-small cell lung cancer as part of Biodesix’s Lung Diagnostics portfolio.
“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,” says Steve Kulisch, vice president of product management, Life Science Group, Bio-Rad Laboratories, in a release. “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.”
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