We are committed to continuously add to our growing body of clinical evidence by publishing and presenting new data and insights on the clinical validation and utility of our diagnostic tests.
The ORACLE registry study was designed to develop real-world clinical utility data for the Nodify XL2® test and is titled “An Observational Registry Study to Evaluate the Performance of the Nodify XL2 Test”. The study objectives are to show a reduction in invasive procedures on patients with benign nodules compared to a historical control obtained from chart review.
The ALTITUDE clinical utility study is designed to evaluate the performance of Nodify Lung (the Nodify XL2® and Nodify CDT® tests) in a randomized controlled study. The study is titled “A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Test in Incidentally Discovered Low to Moderate Risk Lung Nodules”. The study objectives are to evaluate how the addition of the Nodify Lung test result impacts the clinical decision making for patients with new, incidentally identified solid lung nodules assessed as low to moderate risk of lung cancer.
The INSIGHT observational study is designed to evaluate the real-world clinical utility and performance of the Biodesix Lung Reflex (GeneStrat and VeriStrat tests) testing strategy. The title is “Observational Study Assessing the Clinical Effectiveness of VeriStrat and Validating Immunotherapy Tests in Subjects with Non-Small Cell Lung Cancer (INSIGHT)”. The primary study objective is to describe the impact of the VeriStrat test results on treatment decisions.
In partnership with ALCMI (Addario Lung Cancer Medical Institute), the BEACON-Lung clinical study is intended to evaluate the performance and utility of our proteomic product currently in development, Primary Immune Response, in advanced stage NSCLC patients who express high PD-L1. The study title is “A Biomarker Analysis in High PD-L1 Expressing NSCLC Patients Treated With An Immune Checkpoint Inhibitor (ICI) With or Without Platinum-Based Chemotherapy.” The objectives are to collect biospecimens and evaluate candidate biomarkers to detect early progression on ICI monotherapy versus triplet therapy.