Independent Phase III Data to Be Presented at the 2013 ASCO Annual Meeting
Biodesix, Inc., announced that final results of the first completed biomarker-stratified, validation study in oncology will be presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting, May 31st – June 4th, 2013.
The Randomized Proteomic Stratified Phase III Study of Second Line Erlotinib (E) versus Chemotherapy (CT) in Patients with Inoperable Non-Small Cell Lung Cancer (PROSE) study, evaluates the ability of Biodesix’ VeriStrat® test to differentially predict survival in second-line non-small cell lung cancer patients treated with either erlotinib or standard-agent chemotherapy.
The study’s Prinicpal Investigator Vanesa Gregorc, M.D., of the Department of Oncology at the Scientific Institute of the University Hospital San Raffaele in Milan, Italy, will present the findings at ASCO on Monday, June 3 at 4:30 p.m.
VeriStrat is a multivariate, blood-based, protein test currently available to help physicians guide treatment decisions for patients with advanced non-small cell lung cancer. The test identifies patients who are likely to have good or poor outcomes after treatment with either epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy such as erlotinib or with chemotherapy. VeriStrat is based on Biodesix’ proprietary proteomics platform which enables the discovery of multivariate classifiers that characterize a patient’s condition or likely outcome in response to therapy.
“To add to the clinical validation of a biomarker, it can be beneficial to conduct a prospective, phase III randomized trial that compares alternative treatments within the biomarker groups,” said David Brunel, CEO of Biodesix. “PROSE is the first, prospective, phase III study in oncology that has utilized this robust trial design.”
For more information, visit www.veristratsupport.com
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.
This press release contains statements that are hereby identified as “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the Company’s inability to further identify, develop and achieve commercial success for products and technologies; the risk that the Company’s financial resources will be insufficient to meet the Company’s business objectives; uncertainties relating to the regulatory approval process and changes in relationships with strategic partners. We disclaim any intent or obligation to update these forward-looking statements.
Chempetitive Group for Biodesix Kelly Quigley or Rachel Lear 781-775-3640 Biodesix@Chempetitive.com
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