BOULDER, Colo.--(BUSINESS WIRE)--Biodesix Inc., a molecular diagnostics company dedicated to advancing precision medicine and improved patient care, today announced that its VeriStrat® blood-based prognostic and predictive proteomics test has been approved for inclusion in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Non-Small Cell Lung Cancer (NSCLC).
NCCN Guidelines provide evidence-based, consensus-driven management recommendations that seek to ensure all patients receive preventive, diagnostic, treatment and supportive services that are most likely to lead to optimal outcomes.
The updated NCCN Guidelines recommend clinicians’ use of VeriStrat — a non-invasive, blood-based protein profiling test — to help determine whether patients entering the second line of treatment for NSCLC should be considered as candidates to receive the targeted drug erlotinib (Tarceva®), which offers fewer side effects and greater convenience over standard chemotherapy. The NCCN guidelines state: “Recommended proteomic testing for patients with NSCLC and wild-type EGFR or with unknown EGFR status. A patient with a ‘poor’ classification should not be offered erlotinib in the second-line setting.”
Lung cancer is the leading cause of cancer death in the United States, with an estimated 224,210 new cases in 2014, according to NCCN. The drug erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR - TKI) therapy, is commonly used in NSCLC patients who harbor an activating EGFR mutation. However, only a small percentage of patients have this mutation. For the majority of NSCLC patients without an EGFR mutation or whose mutation status is unknown, VeriStrat helps inform physicians whether or not targeted therapy may be appropriate.
“In spite of all the excitement over targeting driver-mutated lung cancer and novel immunotherapies, the hard fact is that most patients do not have these mutations and do not respond to immunotherapy. It is imperative that we optimize the use of the tools we have for these patients, and it is very clear to me that in unselected EGFR wild-type patients, erlotinib has clinically significant benefit. The use of a test like VeriStrat helps select those patients with wild-type EGFR most likely to benefit from erlotinib, and avoid its use in those who would do better with chemotherapy,” said Dr. David Carbone, Barbara J. Bonner Chair in Lung Cancer Research, President-elect, International Association for the Study of Lung Cancer, Professor of Medicine, Director, James Thoracic Center, James Cancer Center, The Ohio State University Medical Center.
“The goal, from a diagnostic perspective, is to identify patients who differentially respond to available therapies in this devastating disease,” said Dr. Richard Hockett, CMO of Biodesix. “The ability of VeriStrat to provide prognostic and therapeutic guidance to improve patient outcomes is gaining wider recognition as standard of care by inclusion in NCCN guidelines.”
An independent phase III clinical trial (PROSE) for VeriStrat confirmed the test’s results are prognostic and specifically predictive of differential overall survival benefit for erlotinib versus chemotherapy in the second-line setting. Successful trial results were recently published in The Lancet Oncology.
“Biodesix is pleased that VeriStrat is now included in the NCCN Guidelines, which are widely recognized as the standard for clinical policy in oncology,” said David Brunel, CEO of Biodesix. “We believe the NCCN’s decision further demonstrates the importance of VeriStrat in improving survival outcomes for cancer patients, and will open the door to further adoption of this valuable tool in the clinical marketplace.”
NCCN, a not-for-profit alliance that includes 25 of the world’s leading cancer institutions, provides guidelines for treatment of a broad spectrum of cancers for use by clinicians, patients and other health care decision-makers. Access the full NCCN Guidelines at NCCN.org.
Biodesix and VeriStrat are registered trademarks of Biodesix Inc. All other trademarks are the property of their respective owners.
Biodesix is a molecular diagnostics company advancing the development of innovative products for precision medicine. The company provides physicians with diagnostic tests for earlier disease detection, more accurate diagnosis, disease monitoring and better therapeutic guidance which may lead to improved patient outcomes. Biodesix discovers, develops and commercializes multivariate protein diagnostics based on their proprietary mass spectrometry based advanced analytical platform, ProTS®. VeriStrat, a multivariate serum proteomics test, is Biodesix’ first product that is processed in Biodesix’ CLIA-certified laboratory and results are reported in less than 72 hours. In addition to developing novel diagnostics independently, the company also partners with biotechnology and pharmaceutical companies to develop companion diagnostics to improve utility of therapeutic agents. For more information on VeriStrat, please visit www.VeriStratSupport.com. For more information about Biodesix, please visit www.Biodesix.com.