BOULDER, Colo.--(BUSINESS WIRE)--Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, announced today the national launch of its new GeneStrat NGS™ genomic test, a blood-based tumor profiling test. The 52-gene panel includes guideline recommended mutations to help physicians treating advanced- stage lung cancer patients identify targeted therapy mutations, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner.
The GeneStrat NGS test is paired with advanced variant interpretation technology connected to a powerful knowledge database developed by PierianDx. Physicians will now receive a streamlined report, including genomic insights for more precise patient care in an unprecedented 72-hour turnaround time.
The GeneStrat NGS test is paid by Medicare under the National Coverage Determination (NCD) for NGS Manual 90.2 section D by Novitas Solutions.
The Company also announced the launch of its new IQLung™ Treatment Guidance Testing Strategy, which includes the new GeneStrat NGS and a broader view of each patient’s disease state. The testing strategy also includes blood-based proteomic and genomic testing workflows for both early and advanced stage lung cancer that can aid physicians in making treatment decisions. Biodesix plans to add additional tests in development to their IQLung portfolio.
“Initiating treatment as early as possible can help improve patient outcomes,” said Scott Hutton, CEO, Biodesix. “Studies show the length of time to receive tests results impacts how quickly a patient goes on treatment. Current NGS tests can take anywhere from a week to a month to return results. This delay of diagnostic information contributes to patient anxiety and compliance, further delaying treatment when time is imperative in fighting lung cancer. It is our mission to change this paradigm, and we offer tests that provide important results in three days so patients can begin treatment as swiftly as possible.”
Biodesix is a leading data-driven diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix is the first company to offer eight non-invasive tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® targeted test, the GeneStrat NGS™ test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an unprecedented 36-72 hours, expediting time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. Biodesix launched the SARS-CoV-2 ddPCR™ test, the Platelia SARS-CoV-2 Total Ab, and the cPass™ SARS-CoV-2 Neutralization Antibody test (cPass™ Neutralization Test Kit, GenScript, Inc,) in response to the global pandemic and virus that impacts the lung and causes COVID-19. For more information about Biodesix, visit biodesix.com.
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