Biodesix, Inc. (Nasdaq: BDSX) presented new data at the CHEST Annual Meeting 2024 in Boston, Massachusetts, detailing the real-world experience of healthcare providers using the Nodify Lung® Nodule Risk Assessment in over 35,000 patients. The company also announced the launch of the CLARIFY study to expand the data package supporting Nodify Lung testing.
Real-World Data on Nodify Lung®
Kathryn Long, MD, of the Medical University of South Carolina, presented data on the clinical use patterns and national reclassification rates of the Nodify Lung test in a presentation titled "Use of a blood-based biomarker for indeterminate nodules in community settings." The findings are consistent with prior studies, demonstrating the test's ability to up- or down-classify patients into actionable risk categories with clear, guideline-recommended diagnostic plans. Guidelines recommend clinicians assess lung cancer risk in patients with new nodules; up to 80% are assigned a low to moderate risk (5-65% risk of lung cancer), where next steps are unclear. Biodesix's Nodify Lung testing, comprised of the Nodify CDT® and Nodify XL2® blood-based lung nodule tests, is designed to reclassify lung cancer risk to high (>65%) or very low (<5%) categories to better clarify optimal next steps.
CLARIFY Study Launch
The newly announced CLARIFY study will collect patient outcomes and other clinical information on a subset of patients featured in the CHEST presentation. This retrospective chart review will include up to 4,000 patients tested in a real-world clinical setting. The study is designed to confirm the performance of the Nodify CDT and Nodify XL2 tests in diverse patient subgroups and expand the evidence characterizing the validation and utility of Nodify Lung testing.
Expert Perspectives
"Nodify Lung testing has changed the standard of care for characterizing risk of malignancy in lung nodules over the past four years, and we are thrilled to share the aggregate experience of healthcare providers using Nodify Lung testing in clinical practice," said Scott Hutton, Chief Executive Officer of Biodesix. "CLARIFY represents the opportunity to supplement this dataset with further clinical outcomes analysis and increase healthcare providers’ confidence in clinical decision-making across distinct patient populations, in various practice settings."
Additional Presentations
On Wednesday, October 9, Sonali Sethi, MD, FCCP, Cleveland Clinic, and D. Kyle Hogarth, MD, FCCP, University of Chicago, discussed the "Patient impact and case studies: the real-world value of biomarkers in lung nodule management" at Learning Theater 4. This presentation reviewed Nodify Lung case studies and the impact that the results have on the patient experience and shared decision-making.
