Core Insights - Biodesix has signed an expanded partnership agreement with Bio-Rad to develop and clinically validate the ddPLEX ESR1 Mutation Detection Assay for advanced breast cancer testing [1][2][4] - The assay will enable highly sensitive detection and quantification of multiple ESR1 mutations from ctDNA samples, which is critical for HR+/HER2- advanced breast cancer treatment [2][3] - Biodesix plans to offer the validated assay as a test service at its accredited CLIA-CAP laboratory and will seek reimbursement through the Centers for Medicare & Medicaid Services (CMS) [3] Company Developments - The first assay to be validated under the agreement is Bio-Rad's ddPLEX ESR1 Mutation Detection Assay, which is essential for the new generation of therapies known as oral selective estrogen receptor degraders (SERDs) [2] - Biodesix aims to improve clinical care and outcomes for patients through its diagnostic solutions, including the Nodify Lung® Nodule Risk Assessment and IQLung® Cancer Treatment Guidance [5] Market Impact - The emergence of ESR1 mutations as biomarkers for breast cancer has significantly increased global demand for rapid and sensitive assays in the oncology market [4] - The collaboration between Biodesix and Bio-Rad is expected to enhance access to sensitive biomarker detection for advanced breast cancer, addressing clinical needs with speed and precision [4] Upcoming Events - Both companies will present more details on their R&D visions, partnerships, and commercial roadmaps at the upcoming AMP conference scheduled for November 11-15 in Boston, MA [4]