The new approach will use AI to analyze CT scans alongside blood-based biomarkers to help doctors determine whether lung nodules may be cancerous.
Biodesix Inc announced the addition of digital diagnostics to its lung diagnostics strategy, creating a multimodal platform that combines blood-based biomarkers, imaging biomarkers, and artificial intelligence (AI). Developed in partnership with Vanderbilt University and Vanderbilt Health, the initiative’s first product is a radiomics-based test designed to assess lung nodule risk and complement the company’s existing Nodify Lung portfolio.
Initial performance data for the radiomics test will be presented on Dec 3, 2026, at the Radiological Society of North America (RSNA) Annual Meeting, with commercial availability anticipated in 2028.
“We believe the future of lung diagnostics will be multimodal,” says Scott Hutton, CEO of Biodesix, in a release. “Digital Diagnostics represents a significant expansion of our strategy, bringing blood-based biomarkers, imaging biomarkers, and 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.”
Combining Radiomics and Blood Biomarkers
The first product under development applies AI to extract quantitative imaging features from medical scans, such as computed tomography (CT), with an emphasis on high specificity. Millions of patients undergo evaluation annually for pulmonary nodules and respiratory conditions, where clinicians must routinely determine whether to pursue invasive biopsy or continue imaging surveillance.
By pairing novel imaging biomarkers with established blood-based testing, the company aims to offer clinicians a more complete evaluation of lung cancer risk than either modality can deliver independently.
“Every day in my clinic I see patients with pulmonary nodules confronting the possibility of lung cancer and asking what comes next,” says Fabien Maldonado, MD, MSc, executive medical director of the Vanderbilt Lung Institute, professor of medicine and thoracic surgery, and director of Vanderbilt interventional pulmonology research, in a release. “Patients want to know whether they should proceed toward a biopsy or continue with imaging surveillance. Several years ago, our research demonstrated that imaging and blood biomarkers provide complementary information and can meaningfully improve the accuracy of lung cancer risk assessment. The challenge has been translating that science into a practical solution that physicians can use at scale. We are excited to help bring a multimodal diagnostic approach into routine clinical practice.”
Clinical Evidence and Commercial Roadmap
Biodesix is the first diagnostics company recognized as an industry affiliate of the Vanderbilt Lab for Immersive AI Translation, a program established to accelerate clinical translation of AI research. The internal initiative is led by Michael Kammer, PhD, who joined Biodesix in 2025 to oversee the digital diagnostics roadmap, regulatory planning, and clinical validation.
“What makes this opportunity particularly compelling is the ability to bring together complementary strengths from both organizations,” says Kammer in a release. “Vanderbilt brings world-class expertise in artificial intelligence and imaging science, while Biodesix contributes deep experience in product development, commercialization, reimbursement, and clinical adoption in pulmonary medicine. Together, we are building more than a single diagnostic test. We are creating a multimodal platform designed to support future innovation across a broad range of lung diseases.”
At the RSNA 2026 meeting, Kammer is scheduled to present initial findings titled “High-Specificity Lung Cancer Identification from Whole-Field CT with Kernel Harmonization for Pulmonary Nodule Triage.”
To support clinical validation and reimbursement, Biodesix received Institutional Review Board approval for STRATIFY, a prospective clinical study scheduled to begin in the fourth quarter of 2026. The study is designed to establish a matched dataset connecting blood-based biomarkers, imaging biomarkers, and clinical outcomes.
In preparation for market entry, the company has engaged with the US Food and Drug Administration on regulatory pathways, initiated discussions with Medicare regarding reimbursement, and established an Independent Diagnostic Testing Facility to support clinical testing operations.
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