TEST:

VeriStrat®

P2, N=43, Active, not recruiting, University of Utah | Recruiting --> Active, not recruiting | N=84 --> 43 | Trial primary completion date: Feb 2025 --> Jun 2025

Our findings suggest that the prognostic value of the VeriStrat test may vary based on the treatment regimen. In clinical scenarios utilizing ICI monotherapy for patients with PD-L1 levels <50%, the role of VeriStrat seems more significant. A prospective study with a larger sample size for validation is warranted.

P=N/A; Recruiting --> Active, not recruiting

P=N/A; This newly acquired information improves our understanding of how VS can accurately predict patient response to therapy. It opens up additional studies that can expand our understanding even further.

Furthermore, identifying VS-P group associated with inferior efficacy-toxicity ratio may be of clinical significance in immune-oncology. Further validation in a larger cohort is warranted.

"Biodesix, Inc...announced today that two abstracts will be presented at the International Association for the Study of Lung Cancer (IASLC) 2023 World Lung Conference on Lung Cancer (WCLC). The first presentation showcases a new analysis of the large multi-center observational registry study INSIGHT...demonstrating the ability of the VeriStrat host immune classifier to predict response to immune checkpoint inhibitor (ICI) regimens in patients with advanced stage non-small cell lung cancer (NSCLC)....The second presentation details the performance of a pre-surgical, blood-based Risk of Recurrence test in three independent cohorts."

"Biodesix, Inc...announced today 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). 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....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."

"Biodesix, Inc...announced...that three new scientific abstracts will be presented as part of the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting including a poster presented by Friends of Cancer Research (FoCR) featuring genomic data contributed by Biodesix and other organizations...This poster highlights long term patient outcomes from the ctMoniTR Project, a study evaluating the prognostic value of changes in circulating tumor DNA (ctDNA) in patients treated with targeted therapies. The new data release indicates that ctDNA shows promise as an early endpoint to support drug development and regulatory decision-making."

"Biodesix, Inc...announced...that Wallace Akerley, MD, medical oncologist at the University of Utah Huntsman Cancer Institute, will present new interim data from the large multi-center prospective observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects) (NCT03289780) at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting."

"Biodesix, Inc...announced the award of a U.S. Federal Supply Schedule contract which includes the Veterans Health Administration providing care for U.S. Veterans and Military Health System providing care for active-duty service members and their families. The contract covers the company’s entire lung diagnostic portfolio: Nodify XL2®, Nodify CDT®, VeriStrat®, GeneStrat® ddPCR, and GeneStrat NGS™ testing."

P2; Active, not recruiting --> Completed

P=NA | N=61 | "Biodesix, Inc...announced...will present the results of a retrospective analysis at the IASLC 2022 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC2022) on August 8, 2022 in Vienna, Austria....The analysis from Northwestern University included patients with advanced-stage non-small cell lung cancer (NSCLC) who received Immune Checkpoint Inhibitors (ICIs) as monotherapy or in combination with chemotherapy with PD-L1 <50%. Patients underwent Biodesix’s blood-based VeriStrat proteomic testing from 2016 to 2021. This data demonstrated that the VeriStrat test result was predictive of Progression Free Survival (PFS) and Overall Survival (OS) in patients with NSCLC with low or negative PD-L1 treated with ICIs."