Biodesix Expands Bio-Rad Partnership to Develop Advanced ESR1 Mutation Testing for Breast Cancer
核心洞察
Biodesix (搜索) and Bio-Rad have expanded their partnership to develop in vitro diagnostic assays using Droplet Digital PCR technology for oncology applications, with initial focus on ESR1 (搜索) mutation detection in breast cancer.
The ddPLEX ESR1 (搜索) Mutation Detection Assay will enable highly sensitive detection of multiple ESR1 mutations from ctDNA samples, addressing critical testing needs in HR+/HER2- advanced breast cancer patients.
ESR1 (搜索) testing has become increasingly important due to clinically demonstrated survival benefits from oral selective estrogen receptor degraders (SERDs), driving global demand for rapid and sensitive assays.
Biodesix (搜索), Inc. (NYSE: BDSX) announced on October 22, 2025, an expanded partnership agreement with Bio-Rad Laboratories (搜索) to develop, validate, and commercialize in vitro diagnostic (IVD) assays for oncology applications using Bio-Rad's Droplet Digital PCR (ddPCR) technology on the QX600 platform. The collaboration will focus on enabling highly sensitive detection of multiple genomic markers, with the first assay targeting ESR1 (搜索) mutations in breast cancer.
ESR1 Testing Addresses Critical Clinical Need
The initial focus of the expanded partnership centers on Bio-Rad's ddPLEX ESR1 (搜索) Mutation Detection Assay, which addresses a growing clinical need in HR+/HER2- advanced breast cancer. ESR1 testing has become critical due to 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 circulating tumor DNA (ctDNA) samples.
"The emergence of ESR1 (搜索) 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 at Biodesix (搜索). "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."
Commercial and Clinical Implementation Strategy
Under the agreement, Biodesix (搜索) will conduct the development, clinical validation, and regulatory submissions for the IVD assays. Following regulatory clearance, the company will manufacture and distribute dedicated specimen collection kits for the developed assays. Once validated, the ESR1 (搜索) assay will be offered as a test service at Biodesix's accredited CLIA-CAP laboratory for both biopharma customers supporting targeted therapeutic development and clinical customers for cancer treatment monitoring.
Biodesix (搜索) plans to seek reimbursement for the ESR1 (搜索) assay through the Centers for Medicare & Medicaid Services (CMS), potentially improving patient access to this diagnostic testing.
Building on Established Partnership
The expanded agreement builds on the companies' existing relationship in lung cancer diagnostics. "Through our long-standing relationship with Biodesix (搜索) 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, VP Product Management at Bio-Rad Laboratories (搜索). "Validation of our ddPLEX ESR1 (搜索) kits will further expand our combined capabilities in clinical diagnostics, increasing access to sensitive biomarker detection for advanced breast cancer."
Both companies will provide additional details about their research and development visions, partnerships, and commercial roadmaps at the upcoming AMP conference in Boston, Massachusetts, from November 11-15, 2025, with Bio-Rad hosting a corporate workshop on November 12 at 8:00 AM ET and Biodesix (搜索) presenting at 4:00 PM ET the same day.