Independent Data Demonstrates Clinical Utility of Biodesix®’ Blood-Based Tests
Biodesix’ tests facilitate rapid treatment decisions and prognostic conversations
October 26, 2016, Boulder, Colorado – Data from Gundersen Health System, La Crosse, WI, externally verified the clinical significance of GeneStrat® and VeriStrat® blood-based testing for patients with non-small cell lung cancer (NSCLC). Blood-based Genomic and Proteomic Testing for Newly Diagnosed Lung Cancer Patients to Facilitate Rapid Treatment Decisions and Prognostic Conversations was presented by lead author Jennifer Mattingley, M.D., at the CHEST 2016 annual meeting held October 22nd-26th in Los Angeles, CA.
Dr. Mattingley said, “These study results demonstrated the value of the Biodesix Lung Reflex testing strategy at the time of initial diagnosis of lung cancer. Expediting treatment decisions and having informed prognostic conversations with patients can decrease the time between diagnosis and treatment and offer an improved patient experience for lung cancer patients.”
To evaluate the utility of the Biodesix Lung Reflex™ testing strategy, GeneStrat results were compared to tissue-based mutation results, and VeriStrat outcome analysis included assessment of its ability to stratify newly diagnosed lung cancer patients according to progression free survival (PFS) and overall survival (OS). All results for blood-based testing were available in less than 72 hours (average TAT = 24.1 hours). GeneStrat genomic testing was highly accurate (93% sensitivity, 99% specificity) and 96% concordant with tissue-based mutation results. VeriStrat proteomic testing was prognostic for PFS and OS across all stages of lung cancer. Patients with VeriStrat Good and Poor status had significantly different PFS and OS.
The VeriStrat® and GeneStrat® Tests
Biodesix’ VeriStrat test is a predictive and prognostic blood-based proteomic test for patients with non-small cell lung cancer. The test is used to assess disease aggressiveness by characterizing host response to the tumor, classifying patients as either VeriStrat Good or VeriStrat Poor. The test has been shown to be predictive for EGFR targeted agents after progression on platinum based chemotherapy. The GeneStrat test is a blood-based genomic mutation test that can inform the use of targeted therapies (EGFR T790M, EML4-ALK, KRAS, BRAF). Both VeriStrat and GeneStrat blood-based tests offer results to ordering physicians within 72 hours.
Biodesix® is a molecular diagnostics company advancing the development of innovative blood tests in oncology to enable precision medicine. Biodesix discovers, develops and commercializes multivariate proteomic 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.
 Gregorc, Vanesa et al. "Predictive Value Of A Proteomic Signature In Patients With Non-Small-Cell Lung Cancer Treated With Second-Line Erlotinib Or Chemotherapy (PROSE): A Biomarker-Stratified, Randomised Phase 3 Trial". The Lancet Oncology 15.7 (2014): 713-721.