Biodesix has expanded its collaboration with Bio-Rad Laboratories for the development and clinical validation of in vitro diagnostic (IVD) assays, designed to facilitate the identification of a variety of genomic markers for oncology applications.
The company will leverage Bio-Rad’s Droplet Digital PCR (ddPCR) technology on the QX600 platform for the detection of these markers. Biodesix will also submit regulatory applications for the IVD assays.
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After the receipt of regulatory approvals, the company will produce and distribute specimen collection kits tailored for the assays.
According to the agreement, initially Bio-Rad’s ddPLEX ESR1 Mutation Detection Assay will be validated. The assay will facilitate highly sensitive identification and quantification of Estrogen Receptor 1 (ESR1) mutations from the samples of circulating tumour DNA (ctDNA).
Biodesix CEO Scott Hutton said: “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.”
Post-validation, Biodesix plans to offer the ESR1 assay as a test service in its Clinical Laboratory Improvement Amendments (CLIA)-College of American Pathologists (CAP) laboratory, catering to both biopharmaceutical companies for therapeutic development and clinical customers for cancer treatment monitoring.
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By GlobalDataFurthermore, Biodesix intends to pursue reimbursement for the ESR1 assay via the Centers for Medicare & Medicaid Services (CMS).
Bio-Rad Laboratories Life Science Group product management vice-president Steve Kulisch said: “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.
“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.”
Further insights into the research and development (R&D) efforts, partnerships, and commercial strategies of Biodesix and Bio-Rad will be presented at the forthcoming AMP conference in Boston, US.
