Biodesix Completes Enrollment of INSIGHT Study Assessing Clinical Utility of the VeriStrat® Blood-Based Host Immune Classifier

On June 27, 2023 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that the large multi-center observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat Testing and Validation of Immunotherapy Tests in NSCLC Subjects) (NCT03289780) has completed enrollment of 5,000 patients with non-small cell lung cancer (NSCLC) (Press release, Biodesix, JUN 27, 2023, View Source [SID1234632927]). The study was designed to further validate the utility of the VeriStrat test, a novel predictive and prognostic blood-based host immune classifier, and its ability to support treatment decisions for patients with NSCLC across different therapeutic approaches.

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"The INSIGHT study gives us a unique opportunity to examine real world treatment patterns for lung cancer, the deadliest of all cancers, in the context of patients’ immune response," said Dr. James Jett, co-Chief Medical Officer at Biodesix. "Five-year survival for patients with non-small cell lung cancer is approximately 25 percent, but now we are seeing that with use of this proteomic test, we are able to identify treatment options, particularly those utilizing Immune Checkpoint Inhibitors in addition to standard chemotherapy, that may extend overall survival in select groups of patients."

Results from prior analyses of the INSIGHT study demonstrated that the VeriStrat test stratifies immune checkpoint inhibition (ICI) treatment response in patients with advanced NSCLC. This data demonstrated that those classified as Host Immune Classifier Cold (HIC-C), also known as VeriStrat Poor, had superior median overall survival when receiving ICI plus chemotherapy versus ICI alone, independent of PD-L1 status.

A recent analysis from this study has been accepted for presentation at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer in Singapore in September 2023. Future analyses of the INSIGHT study are planned in 2024, as monitoring of patient outcomes continues.