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Biodesix Advances the Field of Personalized Medicine With the Launch of VeriStrat(R)

May 5, 2009

Test will help oncologists guide treatment of patients with non-small cell lung cancer

BROOMFIELD, Colo., May 5 /PRNewswire/ — Biodesix, Inc. today announces U.S. commercial availability of VeriStrat, a unique, blood-based, proteomic test for patients with advanced stage non-small cell lung cancer (NSCLC). VeriStrat identifies patients who are likely to have good or poor outcomes following treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), such as erlotinib. VeriStrat, in addition to other clinical factors, provides information to help oncologists make more informed decisions regarding treatment selection.

VeriStrat utilizes mass spectrometry paired with Biodesix’ proprietary algorithms to determine a patient’s VeriStrat classification: VeriStrat Good or VeriStrat Poor. The results of a 460 patient, multi-national clinical study indicate that patients identified as VeriStrat Poor have a higher rate of death as compared to patients identified as VeriStrat Good after treatment with EGFR-TKIs (J Natl Cancer Inst. 2007;99(11):838-46). The study also shows that VeriStrat identifies candidates for therapy who may otherwise be excluded based on patient characteristics, such as a history of smoking or tumor tissue histology.

“Clinically, there are two key advantages of using the VeriStrat test,” said Paul Bunn, Professor of Medical Oncology at the University of Colorado Denver and Executive Director of the International Association for the Study of Lung Cancer. “First, this test can help to identify patients who are unlikely to benefit from therapy. EGFR-TKIs are effective for some NSCLC patients, but not all. Oncologists currently rely on patient characteristics, such as smoking history or tissue histology, which offer limited value in determining whether or not a patient will benefit from a specific therapy. Second, this test offers us a noninvasive means to help guide treatment decisions. Most diagnostic tests currently available require tumor tissue, which is often not available in lung cancer patients. Having a diagnostic test that is specific to a therapy and can be accomplished through a simple blood test provides an important advance in the management of patients with advanced NSCLC.”

“The era of personalized medicine is arriving. Physicians will increasingly use diagnostic tools to provide dramatic improvements in the treatment of their patient’s disease. VeriStrat represents a unique advance in the field and is one of the first tests that analyzes proteins instead of genes, or the phenotype instead of the genotype. Using break-through technology to analyze a simple blood sample, VeriStrat classifies patients with different profiles providing oncologists with important information for managing their lung cancer patients,” noted David Brunel, Biodesix CEO. “Our sales force will immediately begin introducing VeriStrat to oncologists in both key centers of excellence and large community practices throughout the U.S.,” said Brunel.

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 EGFR-TKIs. 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 EGFR inhibitors. 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 health care 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.

SOURCE Biodesix, Inc.


Source: newswire



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