Biodesix Receives CE Mark for VeriStrat Specimen Collection and Shipping Kit

Blood-based protein diagnostic predicts differential treatment outcomes for non-small cell lung cancer

Biodesix, Inc., a fully integrated molecular diagnostics company dedicated to personalizing medicine, today announced that it has obtained the CE Mark for its VeriStrat® specimen collection and shipping kit, clearing the company to make VeriStrat results available to physicians in the European Union and other countries recognizing the CE Mark. VeriStrat is a non-invasive, blood-based protein diagnostic that predicts differential treatment outcomes between two types of therapies for second-line treatment of non-operable, advanced non-small cell lung cancer (NSCLC): chemotherapy or the targeted drug erlotinib (Tarceva®). Physicians use VeriStrat results, in combination with other clinicopathological factors, to guide therapy decisions for non-small cell lung cancer patients.

Lung cancer is the most common cancer in the world with an estimated 1.61 million new cases diagnosed per year, according to the most recent data from the World Cancer Research Fund International. Currently, erlotinib, an epidermal growth factor receptor (EGFR) inhibitor, is commonly used in NSCLC patients who harbor an EGFR mutation. However, only a small percentage of patients have this mutation. For the majority of NSCLC patients without an EGFR mutation or whose mutation status is unknown, there is a clinical need for predicative markers that can help physicians make more-informed treatment decisions.

VeriStrat fills that need as the serum-based test provides information for oncologists to help determine whether or not targeted therapy may be appropriate for NSCLC patients without an EGFR mutation, or those whose EGFR status is unknown. This can provide physicians the option of treating patients with erlotinib instead of chemotherapy — a choice that may result in a better quality of life during advanced stages of lung cancer. Likewise, VeriStrat helps physicians consider ruling out the roughly 30 percent of NSCLC patients who are unlikely to benefit from erlotinib and should receive chemotherapy.

Vanesa Gregorc, M.D., of the Department of Oncology at the Scientific Institute of the University Hospital San Raffaele in Milan, Italy, presented results of an independent phase III clinical trial for the VeriStrat test at the 2013 American Society of Clinical Oncology® (ASCO®) Annual Meeting in June. Known as PROSE, the trial is the first completed prospective biomarker-stratified validation study in oncology. This multi-center, randomized proteomic stratified study of 285 patients confirmed that VeriStrat status is prognostic and specifically predictive of differential overall survival benefit for erlotinib versus chemotherapy in the second-line setting.

“PROSE demonstrated that VeriStrat is a predicative test that can provide physicians with clinically useful information about their patients and which treatment will provide the best overall survival,” said Dr. Gregorc.

The results showed that patients whose test results classified them as “VeriStrat Poor” had better survival outcomes on chemotherapy versus erlotinib and that patients who were classified as “VeriStrat Good” had similar survival outcomes when treated with erlotinib or chemotherapy.

“Making VeriStrat results available to physicians for patients in the European Union has been an important goal for Biodesix,” said David Brunel, CEO of Biodesix®. “With the CE Mark for the specimen collection and shipping kit, more physicians can incorporate this valuable new component into the set of tools they need to guide therapy. VeriStrat will allow them to make targeted, timely treatment decisions that can improve survival outcomes and potentially provide a higher quality of life.”

Biodesix and VeriStrat are registered trademarks of Biodesix, Inc. Tarceva® is a trademark of OSI Pharmaceutical, LLC, an affiliate of AstellasPharma US, and Genentech, Inc. All other trademarks are the 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, ProTS®. VeriStrat, a multivariate serum protein test, is Biodesix’ first product developed with ProTS. The commercially available test provides oncologists with information to help them select between erlotinib and single-agent chemotherapy for advanced lung cancer patients. VeriStrat has been studied in over 80 clinical trials and ordered for over 5000 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.

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