Biodesix Secures Medicare Coverage for VeriStrat® Test

Biodesix, Inc. announced that Novitas Solutions has established coverage for the company’s VeriStrat test. VeriStrat, a clinically validated blood-based protein test, helps physicians guide second-line therapy for patients with advanced non-small cell lung cancer (NSCLC). The coverage decision means that more than 49 million eligible Medicare enrollees in the U.S. will now be able to benefit from VeriStrat being a covered diagnostic test, according to specific lung cancer indications outlined by Novitas.

Lung cancer is the most common cancer worldwide, and is the leading cancer killer in both men and women in the United States. The five-year survival rate for lung cancer is roughly 15 percent, illustrating the need for predictive biomarker tests that can identify which therapies are most appropriate for individual patients. VeriStrat fills that role; the test was recently evaluated in a phase III clinical trial, with data presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting. Results confirmed that VeriStrat is predictive of differential treatment outcomes for the two types of therapies used in second-line treatment of advanced NSCLC: chemotherapy or the targeted drug erlotinib (Tarceva®).

Erlotinib, an EGFR inhibitor, is the drug most commonly used in patients who harbor an EGFR mutation. However, only a small percentage of patients have this mutation. The VeriStrat test helps oncologists guide treatment decisions between erlotinib and single agent chemotherapy in advanced lung cancer patients who do not harbor an EGFR mutation or whose mutation status cannot be obtained. VeriStrat requires only a simple blood draw and test results are returned in less than 72 hours, allowing physicians to make quick treatment decisions.

“Medicare’s decision to offer VeriStrat as a covered benefit will allow those patients enrolled in Medicare to benefit from better-informed, personalized decision-making when it comes to the treatment of their disease,” said David Brunel, Chief Executive Officer of Biodesix. “This is a major milestone for both Biodesix and for patients with lung cancer. Using the information from VeriStrat test results, physicians can improve patient outcomes by identifying the best course of treatment.”

Medicare’s positive coverage decision for VeriStrat, published in Novitas’ “Biomarkers for Oncology” Local Coverage Decision (LCD), describes multiple predictive and prognostic biomarkers in multiple tumor types. VeriStrat is included in the non-small cell lung cancer (NSCLC) section.