Biodesix® Announces Additional Data in Phase III Lung Cancer Diagnostic Study

Biodesix, Inc., a fully integrated molecular diagnostic company dedicated to personalizing medicine, today announced additional data from the Phase III clinical trial for its serum protein test, VeriStrat®. Results were presented at the 15thWorld Conference on Lung Cancer in Sydney, Australia.

“PROSE data confirms VeriStrat can predict differential treatment outcomes in second-line advanced NCLSC patients; VeriStrat is the only available clinically validated test that can do this. This is the first of a number of tests Biodesix will be introducing to provide clinically relevant information to physicians.”

Principal Investigator Vanesa Gregorc, M.D., presented primary and new secondary data from PROSE (Randomized Proteomic Stratified Phase III Study of Second-Line Erlotinib versus Chemotherapy in Patients with Inoperable Non-Small Cell Lung Cancer) — the world’s first successful, prospective biomarker-stratified study in lung cancer to test treatment and biomarker interaction. As originally reported at the 2013 Annual Meeting of the American Society of Clinical Oncology ®, PROSE metp its primary endpoint, which confirms that this serum protein test is predictive of differential treatment outcomes between two types of therapies for second-line treatment of advanced non-small cell lung cancer (NSCLC): single-agent chemotherapy or the tyrosine kinase inhibitor drug, erlotinib (Tarceva®).

VeriStrat is the only test that helps oncologists guide treatment decisions between erlotinib and single-agent chemotherapy in advanced lung cancer patients who are either EGFR wild-type or whose EGFR mutational status cannot be obtained.

“Trial results have demonstrated that VeriStrat is predictive of significant differential treatment benefit between erlotinib and single-agent chemotherapy,” said Dr. Gregorc, Department of Oncology at the Scientific Institute of the University Hospital San Raffaele in Milan, Italy. “In my opinion, while erlotinib has been established as a clinically relevant therapy for unselected patients with NSCLC in the second line setting, we also learned from PROSE that about 30 percent of these patients receive more benefit with chemotherapy. Because of that, when considering erlotinib in this setting, it is important to use VeriStrat to find out which treatment options are appropriate for these patients.”

Dr. Gregorc presented the following data on primary and secondary endpoints:

• PROSE achieved its primary endpoint, demonstrating that VeriStrat is predictive of overall survival.
• For the secondary endpoint of predicting progression-free survival, interaction was not significant. There was no statistically significant difference between chemotherapy and erlotinib for patients classified as VeriStrat Good. For patients classified as VeriStrat Poor, the benefit of chemotherapy over erlotinib trends toward significance.
• For the secondary endpoints of disease control rate and objective response rate, no complete responses were observed in the study and there was no significant difference between the response rates of treatment arms of the VeriStrat groups. However, VeriStrat Poor patients fared better on chemotherapy.

“Lung cancer is the most common cancer worldwide, and predictive biomarker tests such as VeriStrat fill an important role in identifying which therapies are most appropriate for individual patients,” said David Brunel, Chief Executive Officer of Biodesix. “PROSE data confirms VeriStrat can predict differential treatment outcomes in second-line advanced NCLSC patients; VeriStrat is the only available clinically validated test that can do this. This is the first of a number of tests Biodesix will be introducing to provide clinically relevant information to physicians.”

Earlier this year, Novitas Solutions, the Medicare Administrative Contractor for the region that includes Colorado, published a Local Coverage Decision for Biomarkers for Oncology that included positive coverage for VeriStrat according to specific lung cancer indications as outlined in the policy. As a result, more than 49 million eligible Medicare enrollees in the U.S. have access to VeriStrat as a covered test.

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

About Biodesix

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.