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The GeneStrat® Liquid Biopsy Test Earns Approval from NY State-CLEP


Biodesix® Laboratory Also Certified by CAP, CLIA, ISO 35485

Biodesix, Inc. announced today that the GeneStrat test has been approved by New York State's Clinical Laboratory Evaluation Program (CLEP). Approval for the GeneStrat test by CLEP is the most recent of a number of demanding certifications earned by Biodesix’s onsite laboratory, which has now been certified by CLEP, CAP, CLIA, ISO 135485 and five other states.

"We are proud to be able to offer patients and physicians a truly best-in-class liquid biopsy test for lung cancer," said Biodesix CEO David Brunel. "This new approval from New York State/CLEP is further proof that Biodesix is committed to meeting the highest standards of accuracy and reliability.”

The GeneStrat test is a blood-based genomic test for patients with lung cancer that can inform the use of targeted therapies; test results are available within 72 hours. The test delivers results for EGFR sensitizing; EGFR resistance (T790M), KRAS, and BRAF mutations; and EML4-ALK, ROS1 and RET fusion variants. The liquid biopsy test measures circulating tumor DNA and RNA with a highly-sensitive droplet digital PCR platform.

The GeneStrat test is both widely reimbursed and supported by peer-reviewed scientific studies. The genes tested in GeneStrat are covered by Medicare and many private payers. The most recent publication supporting the clinical use of GeneStrat is The Journal of Molecular Diagnostics, "Development and Clinical Utility of a Blood-Based Test Service for the Rapid Identification of Actionable Mutations in Non–Small Cell Lung Carcinoma,” (Mellert, Hestia, et al. May 2017)

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

About Biodesix
Biodesix® is a multi-omic diagnostics company advancing the development of innovative blood tests in oncology to enable precision medicine. Biodesix discovers, develops and commercializes multivariate protein and genomic diagnostic blood tests, including the GeneStrat® and VeriStrat® tests, that deliver results within 72 hours. The company is changing the standard of care by providing physicians with diagnostic tests for better therapeutic guidance, more accurate prognosis and enhanced disease monitoring to improve patient outcomes. At the forefront of precision medicine, Biodesix is developing new blood tests to identify patients who may benefit from immunotherapies. In addition to developing novel diagnostics independently, the company partners with biotechnology and pharmaceutical companies to develop companion diagnostics for use with therapeutic agents.


Topics: Certification from NY State, CLEP certification, GeneStrat lung cancer, Press Releases, liquid biopsy