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May 14, 2009: Biodesix Announces VeriStrat(R) Data in Head and Neck Cancer to be Presented at ASCO
Date:5/14/2009

Data support proteomic test as a predictor of overall survival benefit with EGFRI treatment

BROOMFIELD, Colo., May 14 /PRNewswire/ -- Data on VeriStrat, a blood-based, proteomic test currently used for patients with advanced stage non-small-cell lung cancer (NSCLC), will be presented by Christine Chung, MD, Assistant Professor of Medicine at Vanderbilt University on Monday, June 1st at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO). Results from a 314 patient study indicate that VeriStrat is predictive of survival benefit in patients with squamous cell carcinoma of the head and neck (SCCHN) treated with epidermal growth factor inhibitors (EGFRIs). According to the data, VeriStrat provides information to help oncologists identify patients most likely to benefit from EGFRI therapy.

In the study, VeriStrat was used to classify outcomes in patients with SCCHN who were treated with gefitinib (G), erlotinib and bevacizumab (E/B), cetuximab (C), or palliative chemotherapy (PC). Gefitinib, erlotinib and cetuximab are EGFRIs with activity in SCCHN. Results from the study show that among patients treated with EGFRIs, VeriStrat predicted an overall survival benefit (G: p=0.007, HR 0.41; E/B: p=0.02, HR 0.20; C: p=0.06, HR-0.26). VeriStrat did not classify survival outcomes in patients treated with palliative chemotherapy (PC: p=0.76, HR 0.88).

"At present, there are no validated diagnostic tests to guide therapy selection for patients with SCCHN. Having a blood test that provides results which will help oncologists decide whether or not to treat head and neck cancer patients with anti-EGFR agents would be a major advancement in the treatment of this disease," stated Ezra Cohen, MD, Associate Professor of Medicine at the University of Chicago and a study investigator.

The data support previous study results in which VeriStrat effectively identified patients with NSCLC who were likely to have good or poor outcomes following treatment with EGFRIs (J Natl Cancer Inst. 2007;99(11):838-46). Additional studies are underway to further validate the test and to explore the clinical utility of VeriStrat in other solid epithelial tumors and with other EGFRIs.

A study reporting results evaluating the association of VeriStrat status and genetic features with survival after treatment with erlotinib in patients with NSCLC will also be presented on Saturday, May 30th. For more information on the time and locations of these presentations, visit www.asco.org.

"The data to be presented at ASCO validate our molecular profiling approach to identify patient populations who are most likely to benefit from targeted therapies as well as those who are unlikely to receive any benefit," said Heinrich Roder, D.Phil., Chief Technical Officer at Biodesix. "Biodesix is committed to advancing personalized medicine as we continue our research in identifying the relationship between disease, mass spectrometry profiles and therapies. The data from ASCO, coupled with our previous research, show that VeriStrat is effective at predicting outcomes to therapeutics affecting the EGFR pathway, independent of their specific mode of action, and for tumor types where this is a targeted pathway. This brings us one step closer to a healthcare model that is highly personalized."

About VeriStrat: VeriStrat is a pretreatment serum, proteomic test for patients with advanced NSCLC. The test identifies patients who are likely to have good or poor outcomes after treatment with EGFRIs. Samples are processed in Biodesix' CLIA accredited laboratory and results are typically reported within 72 hours of sample shipment. VeriStrat has been validated in clinical studies with over 1000 patients. Biodesix is engaging in additional studies to further validate the test and to explore the clinical utility of VeriStrat in other solid epithelial tumors and with other EGFRIs. 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 fully integrated molecular diagnostic company enabling personalized medicine using mass spectrometry-based molecular profiling. Working with academic and biopharma collaborators, Biodesix uses its proprietary technology, ProTS(R), to discover and validate diagnostic tests that improve patient outcomes. Biodesix' first product, VeriStrat, is commercially available for physicians to help guide their treatment of patients with non-small cell lung cancer. For more information on Biodesix, 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.


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SOURCE Biodesix, Inc.
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