VeriStrat, a blood-based prognostic and predictive proteomics test by Biodesix Inc, Boulder, Colo, has been approved for inclusion in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology 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.

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 targeted drug erlotinib (Tarceva), 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.


David P. Carbone, MD, PhD

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 candidates to receive erlotinib, 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.”

“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,” says David P. Carbone, MD, PhD, professor of medicine and Bonner chair in lung cancer research at Ohio State University Medical Center, and president-elect of the International Association for the Study of Lung Cancer. “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.”


Richard D. Hockett, MD

“The goal, from a diagnostic perspective, is to identify patients who differentially respond to available therapies in this devastating disease,” says Richard Hockett, MD, 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. The successful trial results were recently published in The Lancet Oncology.1


David Brunel, Biodesix

“Biodesix is pleased that VeriStrat is now included in the NCCN Guidelines, which are widely recognized as the standard for clinical policy in oncology,” says 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 is a not-for-profit alliance that includes 25 of the world’s leading cancer institutions. The network provides guidelines for treatment of a broad spectrum of cancers for use by clinicians, patients, and other healthcare decision-makers. The full NCCN Guidelines can be accessed via the NCCN website.

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. For more information, visit Biodesix.


1. Gregorc V, Novello S, Lazzari C, et al. Predictive value of a proteomic signature in patients with non-small-cell lung cancer treated with second-line erlotinib or chemotherapy (PROSE): a biomarker-stratified, randomized phase 3 trial. The Lancet Oncology. 2014;15(7):713–721; doi: 10.1016/S1470-2045(14)70162-7.