New publication in PLOS ONE, a journal of the Public Library of Science, reaffirms clinical utility of the Nodify XL2® proteomic test in a real-world setting
Biodesix, a leading data-driven diagnostic solutions company with a focus in lung disease, announced that the prospective, real-world ORACLE study (An Observational Registry Study to Evaluate the Performance of the Nodify XL2 Test [NCT03766958]) achieved the primary endpoint of a statistically significant change in the proportion of benign lung nodules managed by Nodify XL2® experiencing invasive procedures. The data was published in PLOS ONE this week.
“The findings from the ORACLE study represent a significant advancement in the clinical evidence for use of the Nodify XL2 test in nodule management”
Lung nodules are a common clinical finding with the increased use of medical imaging for general diagnostic purposes and the expansion of lung cancer screening eligibility. Lung nodules represent an opportunity for early detection of lung cancer but pose a diagnostic dilemma because up to 95% of lung nodules are benign. In this patient population, high rates of invasive procedures, such as biopsies or surgeries, on benign nodules have been documented in the pursuit of lung cancer diagnosis and an analysis of Medicare claims has showed that greater than 40% of the total cost of lung cancer diagnosis was accounted for by biopsied patients without a lung cancer diagnosis.
In ORACLE, the prospective, real-world clinical utility study, patients with benign nodules managed with the Nodify XL2 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 findings from the ORACLE study represent a significant advancement in the clinical evidence for use of the Nodify XL2 test in nodule management,” said Scott Hutton, President and CEO of Biodesix. “Clinical utility is an important step to demonstrate that the test is informing diagnostic decision making in a clinical setting. Avoiding diagnostic procedures on benign nodules reserves healthcare resources for patients with a higher risk of lung cancer, avoids unnecessary interventions for patients, and supports increases in early diagnosis and treatment.”
