A pooled analysis of more than 1,100 patients across four cohort studies supports the clinical utility of the Nodify CDT test in identifying high-risk lung nodules.

Biodesix has announced the publication of what it describes as the largest lung nodule biomarker clinical validation study ever conducted, reinforcing the clinical case for blood-based testing as a decision-support tool in the early detection of lung cancer.

The study, published in Future Oncology in February 2026, analyzed data from more than 1,100 patients with noncalcified lung nodules ranging from 4 to 30 mm in size. The analysis evaluated the performance of the Nodify CDT test across four distinct clinical studies, with patients enrolled from 48 clinical practices across the US.

Consistent Specificity Across Nodule Sizes and Risk Profiles

According to the study, the Nodify CDT test demonstrated high specificity—ranging from 91% to 97%—regardless of nodule size or baseline patient risk factors, indicating low false-positive rates across diverse patient populations. The data also included results from the CLARIFY study (NCT06728319), in which patients received the Nodify CDT test as part of real-world clinical care.

“The data shows that the Nodify CDT test detected lung cancer with minimal false positives for nodules 4-30 mm in size,” says Luke Yuhico, MD, pulmonologist at Fort Walton-Destin Hospital in Florida, in a release. “In my own practice, I have observed that using Nodify Lung testing, in conjunction with the information on the patient’s scan, significantly assists in my team’s decision-making as we strive to meaningfully impact patient outcomes by finding cancer much earlier, even in very small nodules.”

Addressing the Clinical Challenge of Lung Nodule Management

Millions of lung nodules are detected annually in the US, and clinicians routinely face the difficult decision of whether to pursue watchful waiting with imaging surveillance or to expedite intervention—often with limited guidance from computed tomography (CT) scans alone.

James Jett, MD, co-chief medical officer at Biodesix, former pulmonologist at Mayo Clinic, and professor of medicine emeritus at National Jewish Health in Denver, Colorado, points to recent data underscoring the stakes of delayed diagnosis. “A recent study reported in the journal THORAX (by The SUMMIT consortium) observed that over 40% of malignant pulmonary nodules progressed in tumor size between the time of first detection and the time of definitive treatment,” says Jett, in a release. “This highlights a clinician’s need for more helpful decision-support tools to expedite diagnosis and treatment, such as Nodify Lung Nodule Risk Assessment.”

The findings add to a growing body of evidence supporting blood-based biomarker testing as a complement to imaging in pulmonary nodule workup—an area that has drawn increasing attention as lung cancer screening programs expand and the volume of incidentally detected nodules continues to rise.

Implications for Clinical Practice and Payer Coverage

Biodesix CEO and president Scott Hutton highlighted the study’s significance for the company’s broader commercial strategy. “This comprehensive validation study supports our continued commercial expansion of the Nodify CDT test and reinforces its clinical utility in addressing the substantial market opportunity and system-wide gaps in patient care that are presented by lung nodule management,” says Hutton, in a release. “The demonstrated consistency of Nodify CDT tests, across real-world practice settings, further strengthens the company’s offering with healthcare providers, payers, and clinical guideline committees.”

The consistent performance data across 48 practices may be particularly relevant for laboratory and clinical administrators evaluating the test for adoption, as well as for payer coverage decisions and potential inclusion in clinical guidelines. The CLARIFY study component—in which the test was used as part of routine care rather than a controlled trial setting—strengthens the argument for real-world applicability.

The Nodify CDT test is currently available for clinical use in patients with lung nodules measuring 4 to 30 mm. It is marketed as part of Biodesix’s Nodify Lung Nodule Risk Assessment platform, which supports clinical decisions around the earlier identification of lung cancer in patients with pulmonary nodules.

ID 49549963 © Ilexx | Dreamstime.com

Related Reading: