Biodesix, Inc. expects to make an AI-assisted lung nodule imaging test commercially available in 2028 through a partnership with Vanderbilt University and Vanderbilt Health, extending its diagnostics business beyond blood testing.
The proposed test would use artificial intelligence to measure features in computed tomography (CT) scans. Biodesix says it is designing the product for high specificity and to complement its Nodify Lung blood tests. It has not released performance figures for the new test.
The imaging test is the first product in a broader plan to bring scan findings and blood biomarkers into lung risk assessment. Biodesix says the partnership combines Vanderbilt’s imaging expertise with its own product development and commercialization capabilities.
The company’s existing Nodify Lung tests use different methods. Nodify CDT measures seven circulating autoantibodies, while Nodify XL2 combines two blood peptides with clinical information and CT-derived characteristics in its risk algorithm, Biodesix’s 2025 annual filing says.
Biodesix reported $79.2 million in lung diagnostic testing revenue for 2025, up 22% from 2024. It delivered 62,600 tests, a 15% increase. Vanderbilt Lung Institute Executive Medical Director Fabien Maldonado said patients with lung nodules face a choice between proceeding to biopsy and continuing imaging surveillance.
Earlier research offers a precedent for combining different types of evidence, though it did not evaluate the proposed product. In a 2022 study of 338 patients, models using blood proteins, CT image features and clinical factors produced better risk reclassification than the Mayo model.
Biodesix said its STRATIFY study has institutional review board approval and is expected to begin in the fourth quarter of 2026. The study is intended to gather matched blood-marker, imaging-marker and patient outcome data. ClinicalTrials.gov listed it as not yet recruiting in an Oct. 5 update.
Biodesix also reported discussing the test’s regulatory path with the U.S. Food and Drug Administration (FDA), as well as future commercialization with Medicare. Neither clearance for the test nor a Medicare coverage decision was announced. Biodesix plans to present initial performance data at the Radiological Society of North America’s annual meeting on Dec. 3, 2026.
