Biodesix said it will partner with Thermo Fisher Scientific to develop a next-generation sequencing (NGS) assay for use as a blood-based diagnostic solution for advanced non-small cell lung cancer (NSCLC).
Biodesix plans to obtain FDA premarket approval for the diagnostic by using Thermo Fisher’s Ion Torrent Oncomine Pan-Cancer Cell-Free Assay to develop all required analytical and clinical data.
Ion Torrent Oncomine Pan-Cancer Cell-Free Assay is designed to enable reproducible detection and analysis of tumor DNA and RNA across all major classes of somatic mutations—including SNVs, indels, CNVs and fusions—from a single vial of blood 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 others. The assay is Thermo Fisher’s broadest to be developed for liquid biopsy clinical research applications.
“A liquid biopsy approach for rapid analysis of patient blood samples for cancer-driving mutations holds great promise for the future of patient care,” Joydeep Goswami, president of clinical next-generation sequencing and oncology for Thermo Fisher Scientific, said in a statement.
Based in Boulder, CO, Biodesix specializes in lung cancer diagnostic solutions designed for use from early diagnosis of lung nodules through late stage cancer. The company offers three best-in class tests for patients with lung cancer, and multiple pipeline tests including one with the potential to identify patients who may benefit from immunotherapies.
Biodesix has integrated its GeneStrat and VeriStrat tests into its Biodesix Lung Reflex strategy, intended to support treatment decisions with results in 72 hours. The Nodify XL2 nodule test, which will be commercially available in the second half of 2019, evaluates the risk of malignancy, enabling physicians to triage patients to the most appropriate course of action.
Upon FDA approval, Biodesix said, it will have a single-site premarket approval (ssPMA) for an NGS liquid biopsy covering actionable markers in cancer. The PMA designation will extend Biodesix collaborations with biopharmaceutical companies for NGS-based biomarker discovery, validation studies, and commercialization capabilities that include regulatory approval and reimbursement for companion diagnostics.
“Building on our expertise in blood-based solutions, this assay expands our lung cancer portfolio to provide physicians with a blood-based NGS assay that provides fast turn around and comprehensive answers,” Biodesix CEO David Brunel said in a statement. “This agreement enables Biodesix to continue innovating much needed cancer diagnostic solutions that service clinical and biopharma partners from early discovery through global distribution.”
Helping toward that end, its two CLIA and CAP-certified clinical laboratories that support the company’s global products, clinical trials, and biopharmaceutical partnerships.
Biodesix also maintains a certification with ISO 13485, a harmonized international standard for quality management system and the company has gained approval from the New York State Department of Health Clinical Laboratory Standards of Practice (NYS CLEP) in soluble and molecular tumor markers.