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Biodesix, Inc. Release: VeriStrat® Test Predicts Differential Treatment Benefit Between Chemotherapy and Targeted Therapy for Lung Cancer Patients


9/10/2012 9:07:18 AM

BOULDER, Colorado and CHICAGO, Sept. 6, 2012 /PRNewswire/ -- Results from the VeriStrat analysis of serum or plasma samples taken from a Phase II study evaluating erlotinib, gemcitabine, and erlotinib plus gemcitabine in elderly advanced NSCLC patients were presented today at the Chicago Multidisciplinary Symposium in Thoracic Oncology. The retrospective analysis showed that the VeriStrat test was able to identify patients more likely to have a slower progression of disease and longer overall survival when treated with either single agent chemotherapy, gemcitabine, or targeted therapy, erlotinib.

Data was presented by Thomas Stinchcombe, MD, Associate Professor of Hematology/Oncology at the UNC Lineberger Comprehensive Cancer Center. VeriStrat testing was performed on pretreatment serum or plasma samples from 105 study patients with classifications of 63 as VeriStrat Good (60%) and 35 as VeriStrat Poor (33%). Results showed in the gemcitabine treated arm, there was no significant difference between patients classified as VeriStrat Good and VeriStrat Poor for both progression free survival (PFS) and overall survival (OS). However, in the erlotinib treated arm, patients classified as VeriStrat Good had a statistically significant improvement in PFS (p=0.002) and OS (p=0.014) compared to patients classified as VeriStrat Poor. Patients classified as VeriStrat Good also had better PFS (p=0.027) and a strong trend toward better OS outcomes (p=0.051) in the erlotinib plus gemcitabine arm compared to patients classified as VeriStrat Poor.

Researchers concluded in multivariate analysis that the VeriStrat test was predictive of both PFS and OS outcomes between erlotinib and gemcitabine arms ( P <0.001, P=0.017, respectively) and that further studies utilizing VeriStrat to select more beneficial treatment regimens for lung cancer patients are warranted.

Dominic Spinella, PhD, Vice President of Clinical Development and Medical Affairs at Biodesix commented "It is exciting to see that VeriStrat consistently, and across multiple studies, identifies patients who may be good candidates to receive erlotinib therapy. Importantly, this is the first study where we have identified a possible treatment option for those patients who are poor candidates for erlotinib: single agent chemotherapy with gemcitabine. These data support a role for VeriStrat in helping oncologists select the most appropriate treatment for their lung cancer patients."

For more information about this study or VeriStrat, visit our website www.biodesix.com.

About VeriStrat
VeriStrat is a blood-based test for patients with cancer that provides fast, clear results on the patient's proteomic profile. The test helps physicians make more informed treatment decisions by identifying patients who are likely to have good or poor outcomes after treatment with specific cancer therapies. Samples are processed in Biodesix' CLIA-certified laboratory and results are reported in less than 72 hours. VeriStrat has been validated in clinical studies with over 3000 cancer 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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