Biodesix Announces New Clinical Data Demonstrating VeriStrat Testing Predicts Survival in Advanced NSCLC and Immunotherapy

Positive Results from Multiple Studies Support Clinical Utility of VeriStrat Testing

BOULDER, Colo.--(BUSINESS WIRE)--Biodesix, Inc. this week highlighted findings from multiple studies demonstrating the significance and clinical utility of its VeriStrat^® blood-based proteomic test as a predictive biomarker for patient survival outcomes and as a diagnostic tool to improve the clinical management of patients with non-small cell lung cancer (NSCLC). This information is vital to implementing optimal treatment strategies for patients and supports disease state monitoring. To date, VeriStrat testing has helped more than 50,000 patients in determining the best treatment for their lung cancer.

“The potential for VeriStrat continues to expand as studies demonstrate relevancy in lung cancer with the latest therapies in development.”

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Biomarker Identification for Immunotherapy

Data from a clinical study that examined the impact of VeriStrat testing on patients receiving immune checkpoint inhibitors (ICIs) as part of their NSCLC treatment strategy, showed that the VeriStrat MS-based proteomic signature has potential as a biomarker for survival outcomes in NSCLC patients receiving immunotherapy. Among NSCLC patients treated with ICIs, VeriStrat-Good classification was associated with significantly increased PFS in comparison to VeriStrat-Poor classification (median PFS of 6.2 vs. 3.0 months, p=0.012), while the differences in OS trended towards significance (median OS, not reached vs. 16.5 months p=0.076). These results were presented by Northwestern University Feinberg School of Medicine Professor Young Kwang Chae, MD, MPH, MBA at the International Association for the Study of Lung Cancer (IASLC) 2019 World Conference on Lung Cancer.

“As an oncologist, my goal is to identify the treatment course that will give each of my patients the best possible outcome,” Dr. Chae stated. “By using VeriStrat, I am able to get a more complete clinical picture of my patient’s state of health, which allows me to work with that individual to determine the path forward that is best for them.”

Improved Clinical Management of Advanced NSCLC Patients Unsuited for Chemotherapy

A recent University College London (UCL) study published in the European Journal of Cancer found that the VeriStrat test improved prognosis accuracy for patients with advanced NSCLC who were considered to be unsuitable candidates for chemotherapy. NSCLC accounts for 80-85 percent of all lung cancers and many patients are not diagnosed until their cancer has advanced to a late stage. Siow Ming Lee, PhD, UCL Professor of Medical Oncology and Chief Investigator of the TOPICAL trial, reported a strong correlation between the results of the VeriStrat test and patient outcomes. This VeriStrat correlation held even when the patients were split into the good and poor ECOG performance status subgroups; VeriStrat Good versus VeriStrat Poor in ECOG 0-1; HR 0.25, p=0.006 and ECOG 2-3; HR 0.60, p=0.002.

“The relationship between the VeriStrat test and survival is a major finding within this patient population, who have generally poor health and are difficult to treat,” Dr. Lee commented. “The VeriStrat test seems to distinguish patients who have a shorter or longer survival. This has never been reported before in this particular patient group.”

The VeriStrat test is a multivariate, mass-spectrometry based test that measures circulating proteins in the blood serum or plasma of patients with NSCLC. Test results assign a good (VS Good) or poor (VS Poor) classification to patient samples. Multiple studies support that patients with a VS Good result have a better prognosis than patients with a VS Poor result, independent of current clinical prognostic indicators and treatment choice. VeriStrat testing has been validated in more than 85 studies with more than 6,600 patients and is covered by Medicare and many private health insurers.

“VeriStrat blood testing continues to help guide treatment decisions as evidenced through these studies and many others,” said Scott Hutton, Biodesix COO. “The potential for VeriStrat continues to expand as studies demonstrate relevancy in lung cancer with the latest therapies in development.”

Veristrat is part of the Biodesix Lung Reflex Strategy^® (BLR), which integrates the GeneStrat^® genomic test. The BLR strategy has been widely adopted across oncology clinics due primarily to its ability to provide a more comprehensive understanding of patients’ health. Through a series of case studies, physicians detail the value offered through GeneStrat and VeriStrat testing, highlighting their ability to optimize treatment strategies, and to inform conversations on prognoses and treatment options with patients.

About Biodesix

Biodesix is a lung cancer diagnostic solutions company addressing the continuum of patient care from early diagnosis of lung nodules through late stage cancer. The company develops diagnostic tests addressing important clinical questions by combining simple blood draws and multi-omics with the power of artificial intelligence. Biodesix is the first company to offer three best-in class tests for patients with lung cancer, and multiple pipeline tests including one with the potential to identify patients who may benefit from immunotherapies. The Biodesix Lung Reflex^® strategy integrates the GeneStrat^® and VeriStrat^® tests to support treatment decisions with results in 72 hours. The Nodify XL2™ nodule test evaluates the risk of malignancy, enabling physicians to triage patients to the most appropriate course of action. Biodesix also partners with the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges. For more information about Biodesix, please visit www.biodesix.com.