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Biodesix, Inc. Release: VeriStrat(R) Test Results Correlate with Survival Outcomes in Advanced Lung Cancer


4/23/2012 9:08:25 AM

BOULDER, Colo., April 20, 2012 /PRNewswire/ -- Results from the combined analysis of two European Phase II trials were presented today at the 3rd European Lung Cancer Conference in Geneva, Switzerland. The VeriStrat retrospective analysis was performed on serum samples from advanced non-squamous non-small cell lung cancer (NSCLC) patients treated with the combination therapy bevacizumab plus erlotinib. Results showed that the VeriStrat test was able to identify patients likely to have better and worse survival outcomes when treated with the combination therapy.

Pretreatment serum samples from 114 patients treated with bevacizumab plus erlotinib were classified as either VeriStrat Good or VeriStrat Poor. The study showed there was a statistically significant difference in overall survival between the two groups. Patients classified as VeriStrat Good had a median overall survival of 13.4 months versus 6.2 months for patients classified as VeriStrat Poor (p=0.0027, HR=0.480, 95%CI:0.294-0.784). Median progression free survival for patients classified as VeriStrat Good was 4.0 months and 3.2 month for patients classified as VeriStrat Poor, but this difference was not statistically significant (p=0.2632, HR=0.768, 95% CI: 0.482-1.223).

Researchers concluded that the VeriStrat test may be useful for clinical decision-making, representing a prognostic and potentially predictive biomarker for treatment with erlotinib and erlotinib combinations. Prospective trials are ongoing, including a Phase III trial in advanced squamous cell lung cancer, sponsored by the European Thoracic Oncology Platform (ETOP).

"These data represent the third study in which we have shown that VeriStrat classification correlates with survival outcomes in lung cancer patients treated with bevacizumab plus erlotinib, " commented David Brunel, CEO of Biodesix. "Although additional data is needed, this study supports the view that VeriStrat may be useful in identifying lung cancer patients that could benefit from the combination of bevacizumab and erlotinib, which is regarded as less toxic than traditional chemotherapy."

About VeriStrat: VeriStrat is a serum proteomic test currently available for patients with advanced NSCLC. The test identifies patients who are likely to have good or poor outcomes after treatment with epidermal growth factor receptor inhibitors (EGFRIs). Samples are processed in Biodesix' CLIA certified laboratory and results are typically reported within 72 hours of sample shipment. VeriStrat has been validated in clinical studies with over 1500 patients. For more information on VeriStrat or to order VeriStrat, visit www.VeriStratSupport.com or call the VeriStrat Support Hotline at 1-866-432-5930.

About Biodesix: Biodesix is a personalized medicine company focused on the development of diagnostic products that inform treatment decisions and improve patient care. The Company's goal is to give physicians more information about the patient and their disease; understanding the clinically meaningful information contained within each patient's molecular profile leads to better care and better outcomes. The Company's unique approach is based on ProTS®, proprietary technology which exploits the power of mass spectrometry and enables the discovery of specific molecular profiles. Biodesix collaborates with clinical investigators to address critical clinical questions, and partners with biotechnology and pharmaceutical companies to develop diagnostics to select patients most likely to benefit from novel therapies. 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.

SOURCE Biodesix



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