Biodesix, a blood-based lung cancer diagnostic solutions provider, has signed an agreement with Thermo Fisher Scientific for a new blood-based next-generation sequencing (NGS) assay.
Biodesix said that it will develop all required analytical and clinical data using Thermo Fisher’s Ion Torrent Oncomine Pan-Cancer Cell-Free Assay to obtain premarket approval (PMA) from the US Food and Drug Administration (FDA) and bring the assay to market.
Using a single vial of blood, the Ion Torrent Oncomine Pan-Cancer Cell-Free Assay can enable reproducible detection and analysis of tumor DNA and RNA across all major classes of somatic mutations including SNVs, indels, CNVs and fusions, within two days.
The cell-free total nucleic acid (cfTNA) assay targets 52 genes across multiple cancer types, including lung, colorectal, breast, pancreatic, thyroid and has broad application for liquid biopsy clinical research applications.
Biodesix CEO David Brunel said: “We are dedicated to providing actionable answers that physicians and patients need by leveraging the best technology available. Building on our expertise in blood-based solutions, this assay will expand our lung cancer portfolio to provide physicians and biopharmaceutical companies with blood-based NGS assays that provide fast turn around and comprehensive answers.
“This agreement enables Biodesix to continue innovating much needed cancer diagnostic solutions that service clinical and biopharma partners from early discovery through global distribution.”
The partnership is aimed at focusing on an NGS-based solution for patients with advanced non-small cell lung cancer (NSCLC).
Biodesix intends to have a single-site PMA (ssPMA) for an NGS liquid biopsy covering actionable markers in cancer, following the FDA approval.
The FDA premarket approval is expected to extend its collaborations with biopharmaceutical companies for NGS-based biomarker discovery, validation studies, and commercialization capabilities that include regulatory approval and reimbursement for companion diagnostics.
Biodesix claimed that it operates two advanced clinical laboratories regulated by the Centres for Medicare & Medicaid Services (CMS) pursuant to the Clinical Laboratory Improvement Amendments (CLIA).
Furthermore, it has received approval from the New York State Department of Health Clinical Laboratory Standards of Practice (NYS CLEP) in soluble and molecular tumor markers. Biodesix labs support the company’s global products, clinical trials, and biopharmaceutical partnerships.