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Investing.com -- Biodesix (NYSE:BDSX) stock rose 10% Wednesday after the diagnostics solutions company announced an expanded partnership agreement with Bio-Rad Laboratories to develop high complexity assays using Droplet Digital PCR technology.
Under the agreement, Biodesix will develop, clinically validate, and submit regulatory filings for in vitro diagnostic assays focused on oncology applications using Bio-Rad’s ddPCR technology on the QX600 platform. Following regulatory clearance, Biodesix will manufacture and distribute specimen collection kits for these assays.
The first test to be validated under the partnership is Bio-Rad’s ddPLEX ESR1 Mutation Detection Assay, which will enable sensitive detection of multiple ESR1 mutations from ctDNA samples. ESR1 testing has become increasingly important in HR+/HER2- advanced breast cancer treatment due to survival benefits from new oral selective estrogen receptor degraders (SERDs).
Once validated, the ESR1 assay will be offered as a test service at Biodesix’s CLIA-CAP accredited laboratory for both biopharma customers developing targeted therapeutics and clinical customers monitoring cancer treatment. The company plans to seek reimbursement for this assay 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 partnership builds on the companies’ existing collaboration on applications for non-small cell lung cancer as part of Biodesix’s Lung Diagnostics portfolio.
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