Biodesix’s Nodify Test Shows 91-97% Specificity in 1,100-Patient Study
Biodesix published the largest clinical validation of its Nodify CDT test, analyzing pooled data from 1,100 patients with 4-30 mm lung nodules across four US studies. The analysis demonstrated high specificity of 91-97% regardless of nodule size or patient risk, bolstering the test’s commercial expansion and clinical utility.
1. Study Overview
Biodesix announced publication of the largest lung nodule biomarker clinical validation study to date, pooling retrospective data from 1,100 patients with noncalcified pulmonary nodules measuring 4-30 mm across four distinct cohort studies.
2. Clinical Performance Results
The pooled analysis demonstrated Nodify CDT achieved high specificity of 91-97% with low false positive rates across all nodule sizes and baseline risk profiles; results were consistent across 48 clinical practices, including real-world use in the CLARIFY study.
3. Commercial and Clinical Implications
Scott Hutton, CEO and President, stated that the demonstrated consistency strengthens Biodesix’s appeal to healthcare providers, payers and guideline committees, while pulmonologists report that Nodify CDT testing significantly enhances decision-support for earlier intervention.
4. Test Availability and Next Steps
The Nodify CDT test is now available for clinical use in patients with 4-30 mm lung nodules, positioning Biodesix for expanded market penetration and ongoing efforts to integrate the assay into standard lung nodule management pathways.