Biodesix Announces New Clinical and Economic Data for its Nodify Lung® Tests at ISPOR and ATS

Rhea-AI Summary

Biodesix (NASDAQ: BDSX) announced new data presentations for its Nodify Lung® Tests at two major conferences: ISPOR 2025 and ATS 2025. At ISPOR, a study of over 350,000 patients revealed concerning trends in lung nodule management: approximately two-thirds of patients receive no clinical work-up after nodule discovery, 60% of biopsies were performed on benign nodules, and 35% of malignant nodules only received follow-up CT scans before diagnosis.

At ATS 2025, an independent study from Wyckoff Heights Medical Center will present results from 103 patients who received Nodify Lung testing, demonstrating the test's role in lung cancer screening programs and its potential to guide management decisions through actionable results.

Insights

Medical Diagnostics Specialist

Biodesix presents data showing Nodify Lung tests may help address major gaps in lung nodule management while building evidence for clinical adoption and insurance coverage.

Biodesix's presentations at ISPOR and ATS provide compelling evidence for the clinical utility of their Nodify Lung diagnostic tests. The first study, involving over 350,000 patients, highlighted significant gaps in current lung nodule management: approximately 66% of patients receive no clinical follow-up after nodule discovery, while those who do face concerning rates of mismanaged care. Most troubling are the findings that 60% of biopsies were performed on benign nodules (unnecessary invasive procedures) and 35% of malignant nodules only received follow-up CT scans (potentially delayed treatment for cancer).

The second study from Wyckoff Heights Medical Center evaluated Nodify Lung testing in 103 real-world patients, demonstrating "a high proportion of actionable results" that could guide clinical management decisions within a lung cancer screening program. This real-world validation is particularly valuable as it shows how the tests perform in actual clinical settings rather than controlled trials.

These findings address a significant clinical need in pulmonary nodule management. Current risk stratification methods clearly result in both over-treatment (unnecessary biopsies on benign nodules) and under-treatment (delayed diagnoses for malignant nodules). Biodesix's tests appear positioned to help clinicians better triage patients and determine appropriate management pathways. The company is strategically building clinical and economic evidence to support both clinical adoption and, crucially, payer coverage – essential for commercial success in the diagnostic sector. The emphasis on data from a safety-net hospital also suggests potential utility across diverse healthcare settings and patient populations.

LOUISVILLE, Colo., May 15, 2025 (GLOBE NEWSWIRE) -- Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company, announced that new data will be presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2025 Annual Meeting in Montreal, Quebec and at the American Thoracic Society (ATS) 2025 International Conference in San Francisco, California.

The presentation titled “Time to Diagnosis of Lung Cancer from Identification of a Pulmonary Nodule in the United States” was presented yesterday by Kimberly Le, Biodesix Director of Health Economics and Outcomes Research at ISPOR 2025.

This study included over 350,000 patients with medical claims for lung nodules from 2015 through 2017. The results reinforce prior literature findings indicating that approximately two thirds of patients do not receive any clinical work-up after lung nodule discovery, and high rates of over- and under-treatment in those patients who do receive clinical work-up. Importantly, 60% of biopsies were performed on benign lung nodules and 35% of malignant nodules received a follow-up CT scan prior to diagnosis, suggesting the need for better methods to triage patients to expedite the appropriate course of treatment.

The presentation titled “Utilization of Proteomic Testing in Pulmonary Nodule Risk Stratification at a Safety-Net Hospital: An Observational Study” will be presented by Sonu Sahni, MD, Director of Lung Cancer Screening at Wyckoff Heights Medical Center in New York at the ATS 2025 Conference on Monday, May 19 at 2:30 pm ET.

This independent, single-center study characterizes the results of 103 patients who received Nodify Lung testing in real-world clinical practice at Wyckoff Heights Medical Center. The results highlight the role of Nodify Lung testing within a lung cancer screening program and the potential to guide management decisions through a high proportion of actionable results.

“These presentations demonstrate both the challenges in managing large populations of patients with lung nodules and how Biodesix diagnostic testing is being incorporated to augment clinical decision making,” said Kieran O’Kane, Chief Commercial Officer at Biodesix. “These studies contribute to the growing body of evidence that supports the widespread clinical adoption and payer coverage of our tests.”

About Biodesix

Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests, marketed as Nodify Lung^® Nodule Risk Assessment and IQLung™ Cancer Treatment Guidance, support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. For more information, visit biodesix.com.

Trademarks: Biodesix, Biodesix Logo, Nodify Lung, and IQLung are trademarks or registered trademarks of Biodesix, Inc.

Contacts:
Media:
Natalie St. Denis, Director Corporate Communications, Biodesix
natalie.stdenis@biodesix.com
(720) 925-9285

Investors:
Chris Brinzey, Partner, Westwicke
chris.brinzey@icrhealthcare.com
(339) 970-2843

FAQ

What are the key findings from Biodesix's ISPOR 2025 study on lung nodule diagnosis?

The study of 350,000 patients showed that about 2/3 of patients receive no clinical work-up after lung nodule discovery, 60% of biopsies were on benign nodules, and 35% of malignant nodules only received follow-up CT scans before diagnosis.

How many patients were included in the Wyckoff Heights Medical Center study of BDSX's Nodify Lung testing?

The independent, single-center study included 103 patients who received Nodify Lung testing in real-world clinical practice.

Where and when will Biodesix present its new Nodify Lung test data in 2025?

Biodesix will present data at the ISPOR 2025 Annual Meeting in Montreal and at the ATS 2025 International Conference in San Francisco, with the ATS presentation scheduled for May 19 at 2:30 pm ET.

What is the purpose of Biodesix's Nodify Lung testing in clinical practice?

Nodify Lung testing aims to improve lung nodule risk stratification and guide management decisions in lung cancer screening programs through providing actionable results.