Data demonstrates a 51% relative increase in the proportion of lung nodule biopsies diagnosing cancer
BOULDER, Colo.—(BUSINESS WIRE)— Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, announced today that a new analysis from the post-market, prospective, real-world ORACLE study (An Observational Registry Study to Evaluate the Performance of the Nodify XL2 Test NCT03766958) will be presented at the 6th Annual Conference of the American Association for Bronchology and Interventional Pulmonology (AABIP). The data will be presented by principal investigator of the ORACLE study, Michael Pritchett, DO, MPH, on Thursday, Aug. 24, 2023 in a live poster presentation in Chicago, IL.
The Nodify XL2 test is designed to identify likely benign lung nodules that can be monitored with computed tomography (CT) scans instead of costly invasive procedures. The primary endpoint of the ORACLE study demonstrated that patients with benign lung nodules managed with the test were 74% less likely to undergo an unnecessary invasive procedure compared to the control group. Additionally, the proportion of patients sent to CT surveillance with malignant nodules did not differ between the Nodify XL2 group and the control group.
The analysis to be presented at AABIP investigated the effect of improved identification of benign lung nodules on the remaining patients who received a diagnostic biopsy. Prior to implementation of the Nodify XL2 test, 49% of patients receiving a biopsy had a lung cancer diagnosis compared to 74% when the test was used in clinical decision making, representing a 51% relative increase in the cancer diagnosis rate.
“Finding a suspicious lung nodule can create fear and anxiety for patients, whether it is found through lung cancer screening or an incidental finding from imaging for general medical purposes,” said Dr. Pritchett. “It is very encouraging that the Nodify XL2 test is helping physicians avoid unnecessary invasive procedures on benign lung nodules and prioritize patients with a higher risk of lung cancer. These results offer peace of mind to both patients and providers as they navigate the diagnostic plan.”
Biodesix is a leading data-driven diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS® test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, visit biodesix.com.
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