Oct. 22 at 1:00 PM
Biodesix stock rose on Wednesday after announcing an expanded partnership with Bio-Rad Laboratories to develop high-complexity assays using Droplet Digital PCR (ddPCR) technology. Biodesix will develop, validate, and submit regulatory applications for in vitro diagnostic assays focused on oncology, using Bio-Rad’s ddPCR technology on the QX600 platform. After regulatory approval, the company will manufacture and distribute sample collection kits for these assays.
The first assay to be validated is Bio-Rad’s ddPLEX ESR1 mutation test, which will detect multiple ESR1 mutations from circulating tumor DNA. ESR1 testing is key in HR+/HER2- advanced breast cancer treatment due to the survival benefits of new selective estrogen receptor degraders (SERDs). The ESR1 test will be offered through Biodesix’s CLIA-CAP accredited laboratory, for both biopharma and clinical customers. The company also plans to seek Medicare reimbursement.
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