Expanded partnership targets high-sensitivity breast cancer testing

`Biodesix, Inc has expanded its long-standing collaboration with Bio-Rad Laboratories to co-develop and clinically validate high-complexity Droplet Digital™ PCR (ddPCR™) assays for oncology applications. Under the new agreement, Biodesix will lead development, validation, and regulatory submissions for in vitro diagnostic assays based on Bio-Rad’s QX600 platform, including the ddPLEX ESR1 Mutation Detection Assay for advanced breast cancer.

ESR1 mutations are emerging as critical biomarkers in HR+/HER2- advanced breast cancer, guiding the use of next-generation oral selective oestrogen receptor degraders (SERDs). The ddPLEX ESR1 assay enables ultra-sensitive detection and quantification of multiple ESR1 mutations from circulating tumour DNA (ctDNA), supporting precision treatment decisions.

Following validation, Biodesix plans to offer the assay through its CLIA-CAP-accredited laboratory for both biopharma and clinical use, and will pursue CMS reimbursement to expand patient access. The collaboration builds on the companies’ previous success applying ddPCR technology to Biodesix’s Lung Diagnostics portfolio, extending their joint expertise into breast cancer diagnostics.

“Expanding our partnership with Bio-Rad allows us to accelerate development of clinically relevant molecular assays that support targeted cancer therapies,” said Scott Hutton, CEO of Biodesix. “This collaboration demonstrates our shared commitment to delivering high-quality, data-driven solutions that improve patient care.” 

Bio-Rad’s Steve Kulisch, VP Product Management, Life Science Group, added: 

“Our work with Biodesix highlights how Droplet Digital PCR can drive clinical innovation across oncology. Validating the ddPLEX ESR1 kit is a step toward broader access to sensitive biomarker testing in breast cancer.” 

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