Biodesix Adds Digital Diagnostics to Lung Pipeline, Creating New Growth Platform Combining Blood and Imaging Biomarkers
Key Highlights
- ➤Biodesix adds Digital Diagnostics, combining blood, imaging biomarkers, and AI
- ➤Radiomics lung nodule test targets high-specificity risk assessment alongside Nodify Lung
- ➤Commercial availability anticipated in 2028 through Biodesix’s established channels
- ➤Initial test performance data scheduled for RSNA presentation on December 3, 2026
- ➤STRATIFY prospective multimodal study expected to commence in fourth quarter 2026
Expert Statements
Scott Hutton, CEO of Biodesix
“We believe the future of lung diagnostics will be multimodal.”
Scott Hutton, CEO of Biodesix
“Digital Diagnostics represents a significant expansion of our strategy, bringing blood-based biomarkers, imaging biomarkers, and artificial intelligence (AI) together on one platform.”
Scott Hutton, CEO of Biodesix
“Biodesix has the clinical, commercial, and reimbursement capabilities to translate that innovation into solutions physicians can use in practice.”
Scott Hutton, CEO of Biodesix
“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.”
Fabien Maldonado, Executive Medical Director of the Vanderbilt Lung Institute, Professor of Medicine and Thoracic Surgery, and Director of Vanderbilt Interventional Pulmonology Research
“Every day in my clinic I see patients with pulmonary nodules confronting the possibility of lung cancer and asking what comes next.”
Fabien Maldonado, Executive Medical Director of the Vanderbilt Lung Institute, Professor of Medicine and Thoracic Surgery, and Director of Vanderbilt Interventional Pulmonology Research
“Patients want to know whether they should proceed toward a biopsy or continue with imaging surveillance.”
Fabien Maldonado, Executive Medical Director of the Vanderbilt Lung Institute, Professor of Medicine and Thoracic Surgery, and Director of Vanderbilt Interventional Pulmonology Research
“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.”
Fabien Maldonado, Executive Medical Director of the Vanderbilt Lung Institute, Professor of Medicine and Thoracic Surgery, and Director of Vanderbilt Interventional Pulmonology Research
“The challenge has been translating that science into a practical solution that physicians can use at scale.”
Fabien Maldonado, Executive Medical Director of the Vanderbilt Lung Institute, Professor of Medicine and Thoracic Surgery, and Director of Vanderbilt Interventional Pulmonology Research
“We are excited to help bring a multimodal diagnostic approach into routine clinical practice.”
Michael Kammer, Head of Radiomics at Biodesix
“What makes this opportunity particularly compelling is the ability to bring together complementary strengths from both organizations.”
Michael Kammer, Head of Radiomics at Biodesix
“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.”
Michael Kammer, Head of Radiomics at Biodesix
“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.”
LOUISVILLE, Colo., Oct. 19, 2026 (GLOBE NEWSWIRE) -- Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostics solutions company, today announced the addition of Digital Diagnostics to its Lung Diagnostics strategy, establishing the foundation for a multimodal diagnostic platform that combines blood-based biomarkers, imaging biomarkers, and artificial intelligence. The first product, a radiomics-based test for lung nodule risk assessment developed with Vanderbilt University and Vanderbilt Health, is designed to complement the Nodify Lung® portfolio and represents the next phase of innovation in lung diagnostics. Initial data for this new test will be presented at RSNA on December 3, 2026, and commercial availability is anticipated in 2028.
The Digital Diagnostics initiative extends the Biodesix blood-based lung diagnostics franchise into imaging, which is central to clinical evaluation of many pulmonary conditions. Biodesix is uniquely positioned to commercialize multimodal lung diagnostics through its established testing portfolio, national commercial infrastructure, reimbursement expertise, regulatory capabilities, and deep relationships with pulmonary and primary care physicians. By integrating complementary sources of diagnostic information, Biodesix aims to deliver a more comprehensive assessment of lung cancer risk than either modality can deliver alone and to build a scalable platform that can support future products across a broad range of lung diseases.
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