BOULDER, Colo.–(BUSINESS WIRE)–Apr 2, 2013–Biodesix, Inc., a molecular diagnostic company dedicated to personalizing medicine, today announced the online release of a peer-reviewed study demonstrating that physicians are using the company’s VeriStrat test to help guide treatment decisions for patients with advanced non-small lung cell cancer (NSCLC).
“The results of this study show that when physicians incorporated the VeriStrat test into their clinical practice, it had a significant impact on their treatment decisions,” said David Brunel, CEO of Biodesix. “This data confirms that VeriStrat provides valuable information to physicians as they recommend a therapy for individual patients—particularly patients with advanced NSCLC who may not be receiving personalized therapy due to lack of a genetic mutation or squamous histology.” VeriStrat is a novel, multivariate, serum protein test designed to provide oncologists with information to help them choose between erlotinib and single-agent chemotherapy when treating advanced lung cancer patients. The test, which requires only a simple blood draw, provides results in less than 72 hours, allowing physicians to make quick treatment decisions.
The published study, titled “The Impact of Serum Based Proteomic Mass Spectrometry Test on Treatment Recommendations in Advanced Non Small Cell Lung Cancer,” shows that VeriStrat significantly influences therapy recommendations. The study reveals that 90 percent of physicians’ post-test treatment recommendations positively correlated with results of the VeriStrat test: Physicians overwhelmingly chose erlotinib therapy when a patient’s test resulted in “VeriStrat Good,” but selected alternative therapy when a patient’s test resulted in a reading of “VeriStrat Poor.” In addition, the study showed that 40 percent of post-test treatment recommendations represented a change from the physicians’ pre-test treatment consideration.
“It’s no longer sufficient to only prove the clinical utility of a molecular test. Developers must also provide data early on, and then subsequently validate that data, showing that the test is being adopted and results are appropriately influencing clinical practice,” said John Hornberger, MD, MS, FACP, of Stanford University and Cedar Associates LLC, and an author of the study. “This study is the first showing that early physician users of the test are making clinically relevant practice management changes based on the results of the test.” Previous clinical validation studies of the VeriStrat test have shown that the group of patients classified as “VeriStrat Good” has significantly longer overall survival following treatment with erlotinib when compared with patients who are classified as “VeriStrat Poor.” Most recently, an article in the demonstrated that the VeriStrat test is predictive of differential treatment outcomes between erlotinib and chemotherapy.
Biodesix is a molecular diagnostics company advancing the development of innovative products for personalizing medicine. The company provides physicians with diagnostic tests for earlier disease detection, more accurate diagnosis, disease monitoring and better therapeutic guidance, which may lead to improved patient outcomes. Biodesix discovers, develops and commercializes multivariate protein diagnostics based on their proprietary mass spectrometry-based discovery platform. VeriStrat, a multivariate serum protein test, is Biodesix’ first product developed with this technology. The commercially available test provides oncologists with information to help them select between erlotinib and single-agent chemotherapy for advanced lung cancer patients. Tests are processed in Biodesix’ CLIA-certified laboratory and results are reported in less than 72 hours. In addition to developing novel diagnostics independently, the company also partners with biotechnology and pharmaceutical companies to develop companion diagnostics to improve utility of therapeutic agents. For more information on VeriStrat, please visit www.VeriStratSupport.com. For more information about Biodesix, please visit www.Biodesix.com.