Biodesix Launches GeneStrat | Biodesix


Diagnostic Test Reveals Actionable Mutations; Results Returned Within 72 Hours

Biodesix, Inc. today announced the launch of GeneStrat™, a targeted liquid biopsy mutation test for genotyping tumors of patients with advanced non-small cell lung cancer (NSCLC).  The blood test results are available within 72 hours, providing physicians actionable diagnostic information prior to making treatment decisions. GeneStrat is focused exclusively on the clinically actionable EGFRKRAS, and BRAF mutations often used to guide targeted therapy treatment decisions. GeneStrat also captures the EGFR T790M mutation, which can be used for monitoring the emergence of the primary resistance mutation in the EGFR gene. It is anticipated that two drugs targeting the resistance mutation may be available later this year. GeneStrat uses the ddPCR platform to analyze cell-free tumor DNA and is highly concordant with tissue analysis, currently considered the gold standard.

Roughly 30% of lung cancer patients either have insufficient biopsy tissue or are not candidates for a biopsy for tumor mutation profiling.  Even in cases where tissue biopsy is available, the sense of urgency to treat is great, with one recent study showing that one out of four patients begin cancer treatment before receiving mutation test results. Requiring only a blood draw, GeneStrat offers a fast, minimally invasive alternative to a high-risk tissue biopsy or re-biopsy in patients with insufficient tissue.

In addition to providing a minimally-invasive source of mutation status, liquid biopsy can be more cost-effective than traditional tissue biopsies. The mean cost of each tissue biopsy is $14,634 across all patients. The cost of a tissue biopsy can be up to four time higher in the 19.3% of patients who have complications associated with the biopsy. GeneStrat liquid biopsy can help avoid the cost and complications of repeat tissue biopsy.

“Being diagnosed within 72 hours of a blood test is critical to rapid treatment decisions, as over half of people with lung cancer die within one year of their initial diagnosis,” said David Brunel, Biodesix’ CEO. “GeneStrat provides the tumor mutation profile at the time of diagnosis and can be used to monitor resistance by tracking the rise of the EGFR T790M mutation. For a more complete picture of the patient’s disease, GeneStrat can also be paired with VeriStrat®, which captures the host response to the tumor – prognostic information early in treatment planning and predictive information for patients who are ineligible for platinum doublet chemotherapy or after progression on first line treatment. These tests help physicians offer personalized treatment plans and enable more informed disease management strategy discussions with patients, without the need for more invasive and costlier tissue biopsies.”

Biodesix, VeriStrat and GeneStrat are trademarks or registered trademarks of Biodesix, Inc.  All other trademarks referenced herein are property of their respective owners. 

About Biodesix
Biodesix® is a molecular diagnostics company advancing the development of innovative blood-based tests – GeneStrat™ and VeriStrat® – in oncology for precision medicine. The company provides physicians with diagnostic tests for earlier disease detection, more accurate diagnosis, disease monitoring and better therapeutic guidance, which can lead to improved patient outcomes. Biodesix discovers, develops and commercializes multivariate protein and genomic diagnostic tests on various discovery platforms. In addition to developing novel diagnostics independently, the company partners with biotechnology and pharmaceutical companies to develop companion diagnostics to improve utility of therapeutic agents.

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Topics: liquid biopsy, Genestrat liquid biopsy, In the News, cost of lung cancer biopsy