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VeriStrat® Results Correlate with Survival Outcomes in Kidney Cancer Patients
Date:10/14/2011

BROOMFIELD, Colo., Oct. 14, 2011 /PRNewswire/ -- Data presented at the 10th International Kidney Cancer Symposium being held in Chicago, IL show that the pretreatment blood-based test, VeriStrat, was able to stratify renal cell carcinoma (RCC) patients treated with a combination of two targeted therapies, sunitinib (Sutent®) and erlotinib (Tarceva®), by survival outcomes.   Patients who tested VeriStrat Good had significantly longer progression free survival (PFS) and overall survival (OS) when treated with the combination therapy as compared to patients who tested VeriStrat Poor.  

The study retrospectively, and in a fully blinded fashion, applied the VeriStrat test to a subset of the patient population from a Phase I/II clinical trial of erlotinib plus sunitinib in RCC patients.  VeriStrat analysis was performed on all available serum samples.   Thirty-seven of 46 patients were classified as either VeriStrat Good or VeriStrat Poor based on the VeriStrat algorithm developed for non-small cell lung cancer (NSCLC).

The analysis showed that VeriStrat Good patients had a significantly longer PFS and OS versus VeriStrat Poor patients (PFS: median 12.3 vs. 4.7 months, log-rank p=0.025 and OS: median 38.4 vs. 11.6 months, log-rank p=0.045).   There was a statistically significant correlation between VeriStrat classification and Heng prognostic criteria, but not MSKCC classification.   VeriStrat showed the potential to further refine current grouping of RCC patients, separating MSKCC intermediate patients into VeriStrat Good and VeriStrat Poor subgroups with statistically significantly different PFS (log-rank p = 0.030).

Heinrich Roder, D.Phil., Chief Technology Officer of Biodesix stated, "This data set shows that our test, VeriStrat, may be helpful in identifying specific and useful disease characteristics in RCC.   It is also exciting to see that our test is showing utility across multiple solid tumors.   Oncologists currently do not have a simple serum test that can be used across multiple tumor types.   We are continuously engaging in additional studies to further explore the full clinical utility of VeriStrat."

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 accredited 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.

Sutent® is a registered trademark of Pfizer Inc.
Tarceva® is a registered trademark of OSI Pharmaceuticals, LLC, a member of the Astellas Pharma Global Development Inc. group of companies.

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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