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Biodesix to Develop Blood-Based Lung Cancer Diagnostic Using Thermo Sequencing Panel

NEW YORK – Biodesix said today that it has signed an agreement with Thermo Fisher Scientific to develop and seek US Food and Drug Administration approval for a sequencing-based lung cancer liquid biopsy diagnostic test.

Under the agreement, Biodesix will generate analytical and clinical data using Thermo Fisher's Ion Torrent Oncomine Pan-Cancer Cell-Free Assay to apply for premarket approval (PMA) from the FDA. The initiative will focus on patients with advanced non-small cell lung cancer.

Following FDA approval, Biodesix will have a single-site PMA for an NGS-based liquid biopsy test covering actionable markers in cancer, which the company said will better enable it to provide NGS-based biomarker discovery, validation studies, and companion diagnostic commercialization capabilities to biopharmaceutical partners.

"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 turnaround and comprehensive answers," said Biodesix CEO David Brunel in a statement.

The Ion Torrent Oncomine Pan-Cancer Cell-Free assay analyzes all major classes of somatic mutations in cell-free nucleic acid, including DNA and RNA, targeting 52 genes across multiple cancer types.

Biodesix, based in Boulder, Colorado, focuses on lung cancer diagnostics. Its Biodesix Lung Reflex strategy integrates the GeneStrat and VeriStrat tests to support treatment decisions. Its Nodify XL2 nodule test, which will become commercially available in the second half of this year, evaluates the risk of malignancy.

Last month, the company said it will acquire Oncimmune's US operations and the US rights to the firm's blood-based incidental pulmonary nodule test EarlyCDT Lung.