Boulder-based lung cancer diagnostic company Biodesix today announced it has entered an agreement with Thermo Fisher Scientific to bring a blood-based next-generation sequencing analysis to market that has potential for liquid biopsies for cancer.
Next-generation sequencing is a “methodology that enables rapid sequencing of the base pairs in DNA or RNA samples, according to Thermo Fisher Scientific.
The partnership has U.S. Federal Drug Administration premarket approval — a “process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices, according to the FDA. “Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.”
Biodesix will work to develop all required analytical and clinical data using Thermo Fisher’s Ion Torrent Oncomine Pan-Cancer Cell-Free Assay in an effort to obtain regulatory approval from the FDA, according to a news release. The program will focus on a next generation sequencing-based solution for patients with advanced non-small cell lung cancer, according to the release.
The Ion Torrent Oncomine Pan-Cancer Cell-Free Assay enables reproducible detection and analysis of tumor DNA and RNA across all major classes of somatic mutations from a single vial of blood within two days, according to the release. Targeting 52 genes across multiple cancer types, including lung, colorectal, breast, pancreatic, thyroid and others, the test has broad application for liquid biopsy clinical research applications, the release stated.
Upon FDA approval, Biodesix will have a single-site premarket approval for an next generation sequencing liquid biopsy covering actionable markers in cancer, according to the release.
“We are dedicated to providing actionable answers that physicians and patients need by leveraging the best technology available,” David Brunel, Biodesix CEO, stated in the release. “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 (next generation sequencing) assays that provide fast turnaround 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.”