Biodesix announces the enrollment of initial subjects into CASTLE, the inaugural study of the Addario Lung Cancer Medical Institute (ALCMI, pronounced as “Alchemy”). The CASTLE (Collaborative Advanced Stage Tissue Lung Cancer) study is recruiting a minimum of 250 subjects over two years among academic and community medical centers in the United States. The study collects biospecimens and data from lung cancer patients in order to facilitate and accelerate the development and delivery of diagnostic tests and treatments tailored to the individual patient. As part of the study, Biodesix is performing VeriStrat® testing on eligible patients and serving as ALCMI’s biorepository for all serum samples collected from CASTLE study subjects for future research. VeriStrat is a serum proteomic test for advanced non-small cell lung cancer patients that helps physicians determine if a patient should receive treatment with a drug called erlotinib.
Biodesix is committed to advancing the field of personalized medicine by developing unique and clinically useful diagnostic tests in oncology. This collaboration is the first of its kind in bringing together leading lung cancer scientists in the U.S. and Europe, patient advocates, and diagnostic laboratories to collect biospecimens with the intent of developing personalized therapies and tests that could improve patient outcomes. “We are pleased to offer the only serum-based testing for the CASTLE study and play an integral role in this collaboration” commented Paul Beresford, Biodesix’ Vice President in charge of the company’s laboratory operations. “We look forward to supporting our ALCMI colleagues in their efforts to accelerate translational medicine in lung cancer and continuing to shift the standard of care toward widespread use of molecular testing in clinical decision-making.”
About NSCLC: As reported by the American Cancer Society, lung cancer is the leading cause of cancer death in the US. NSCLC represents approximately 87% of lung cancer. An estimated 215,000 new cases of lung cancer and 162,000 deaths due to lung cancer occurred in the US in 2008. Treatment options include surgery, radiation therapy, chemotherapy and targeted biological therapies such as bevacizumab (Avastin®) and erlotinib (Tarceva®). Less than 5% of advanced NSCLC patients survive for 5 years, emphasizing the need for improved patient selection to maximize drug efficacy.
About VeriStrat: VeriStrat is a proteomic serum test 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. 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 developing products that support excellence in clinical decision making and improve patient care. The Company’s goal is to give physicians more information to understand 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 that can be used to better characterize the patient and their disease. Biodesix collaborates with investigators to address key clinical questions, and partners with biotechnology and pharmaceutical companies for development of companion diagnostics and improved targeting of therapies in clinical trials. For more information about Biodesix, please visit the Company’s website at 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.