On April 28, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported their plan to add a blood-based 52-gene next generation sequencing (NGS) test to their portfolio of molecular testing based on a recent publication (Press release, Biodesix, APR 28, 2021, View Source [SID1234578664]). Of critical importance, the publication, "Targeted Next-Generation Sequencing of Liquid Biopsy Samples from Patients with NSCLC," in Diagnostics showed that the rapid liquid biopsy testing was able to detect actionable genomic alterations in patients with non-small cell lung cancer (NSCLC) with an unmatched turnaround time of only 72 hours.
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The test has been in use for biopharma research testing and is performed in Biodesix’s ISO 13485-certified, New York Clinical Laboratory Evaluation Program (CLEP)-approved, College of American Pathologists (CAP)-accredited, Clinical Laboratory Improvement Amendments (CLIA)-high complexity certified clinical testing laboratory. With the turnaround time for existing, on-market liquid biopsy NGS tests ranging from 7-14 days, improving turnaround time to three days can be critical for patients with advanced NSCLC who are unable to undergo biopsy or whose biopsies have yielded insufficient test results.
"We observed significant agreement (95.7%–100%) with an orthogonal, high-sensitivity Droplet Digital Polymerase Chain Reaction (ddPCR) test," said Gary Pestano, Ph.D., Chief Development Officer at Biodesix. "This method offers a valuable supplement to assessing targeted mutations from blood while conserving specimens and maintaining sensitivity, with rapid turnaround time to actionable results."
The NGS test will complement the now 36-hour turnaround time that GeneStrat ddPCR and VeriStrat tests currently offer with the expanded coverage of 52-genes and broader molecular markers. The 52-gene NGS test will be used for advanced, late-stage, or recurrent cancer mutation detection, and the targeted 6-gene GeneStrat test can be used for identification of the select mutations for treatment guidance, recurrence monitoring, and detection of the development of resistance mutations over time. The company expects to begin offering this testing strategy in the first half of 2022.
"This test allows Biodesix to offer comprehensive molecular test results, with small and large genomic testing panels in combination with our immune profiling test for early and advanced NSCLC," said Scott Hutton, CEO of Biodesix. "We believe that by adding this NGS test to our current portfolio and multi-omics approach, we can enable physicians to make critical treatment decisions for their patients across the continuum of care in the shortest amount of time available today."