Biodesix (NASDAQ:BDSX) saw its stock jump 10% on Wednesday after announcing an expanded partnership with Bio-Rad Laboratories to advance the development of high-complexity oncology assays using Droplet Digital PCR technology.
Under the new agreement, Biodesix will lead development, clinical validation, and regulatory submissions for in vitro diagnostic assays built on Bio-Rad’s ddPCR technology, running on the QX600 platform. Once regulatory clearance is secured, Biodesix will handle manufacturing and distribution of specimen collection kits for these assays.
The first test to be validated through this partnership will be Bio-Rad’s ddPLEX ESR1 Mutation Detection Assay, designed for sensitive detection of multiple ESR1 mutations from ctDNA samples. ESR1 testing plays a critical role in the treatment of HR+/HER2- advanced breast cancer, particularly with the growing use of oral selective estrogen receptor degraders (SERDs) that have shown survival benefits.
Once validated, the ESR1 assay will be offered as a test service at Biodesix’s CLIA-CAP accredited lab, serving both biopharma partners developing targeted therapies and clinical customers monitoring patient response. Biodesix intends to pursue reimbursement for the test 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,” said Scott Hutton, CEO of Biodesix.
This expanded agreement builds on the companies’ existing collaboration in non-small cell lung cancer applications, a key component of Biodesix’s Lung Diagnostics portfolio.