Multimodal Platform to Combine Blood and Imaging Biomarkers for Lung Nodule Assessment

With millions of patients evaluated each year for pulmonary nodules and other respiratory conditions, clinicians need tools that can improve risk stratification in pulmonology and primary care. A new digital diagnostic platform has now launched to combine blood-based biomarkers, imaging biomarkers, and artificial intelligence for lung nodule risk assessment.

Biodesix (Louisville, CO, USA) has added Digital Diagnostics to its Lung Diagnostics strategy, creating a multimodal platform that combines blood-based biomarkers, imaging biomarkers, and artificial intelligence. The first product is a radiomics-based lung nodule risk assessment test developed with Vanderbilt University and Vanderbilt Health to complement the Nodify Lung portfolio.

The digital diagnostic uses artificial intelligence to extract quantitative features from medical images, including computed tomography (CT) scans. Designed for high specificity, the test can be used alongside established blood-based biomarkers to provide a more comprehensive assessment of lung cancer risk than either approach alone.

Initial performance data for the test are scheduled for presentation on December 3, 2026, under the title “High-Specificity Lung Cancer Identification from Whole-Field CT with Kernel Harmonization for Pulmonary Nodule Triage.” Commercial availability is anticipated in 2028, when the integrated multimodal test portfolio is expected to be offered through established commercial channels.

Biodesix is also advancing the STRATIFY prospective clinical study, which has received Institutional Review Board approval and is expected to begin in the fourth quarter of 2026. The study will generate matched datasets linking blood-based biomarkers, imaging biomarkers, and clinical outcomes. 

Alongside this evidence-generation effort, the company has engaged with the U.S. Food and Drug Administration (FDA) on a regulatory pathway and with Medicare on future commercialization. It has also established an Independent Diagnostic Testing Facility to support clinical testing and expand operational capacity.

“We believe the future of lung diagnostics will be multimodal. Digital Diagnostics represents a significant expansion of our strategy, bringing blood-based biomarkers, imaging biomarkers, and artificial intelligence (AI) together on one platform. Biodesix has the clinical, commercial, and reimbursement capabilities to translate that innovation into solutions physicians can use in practice. We are starting with lung nodule risk assessment, but our vision is much broader—to build a new diagnostic platform capable of supporting innovations across lung disease,” said Scott Hutton, CEO of Biodesix.

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Vanderbilt Health
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