Biodesix, Inc. (Nasdaq: BDSX) has unveiled new clinical and economic data for its Nodify Lung® tests at two major medical conferences, highlighting significant challenges in pulmonary nodule management and demonstrating how their diagnostic solutions can improve patient care.
The diagnostic solutions company presented findings from a large-scale study at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2025 Annual Meeting in Montreal on May 14. The study, titled "Time to Diagnosis of Lung Cancer from Identification of a Pulmonary Nodule in the United States," analyzed medical claims data from over 350,000 patients with lung nodules between 2015 and 2017.
Kimberly Le, Biodesix's Director of Health Economics and Outcomes Research, presented concerning results that reinforce previous findings about significant gaps in lung nodule management. Approximately two-thirds of patients received no clinical work-up following nodule discovery, while those who did receive follow-up care often experienced inappropriate management.
"The data revealed alarming rates of both over- and under-treatment," explained Le. "Sixty percent of biopsies were performed on what turned out to be benign nodules, representing unnecessary invasive procedures. Conversely, 35% of malignant nodules only received follow-up CT scans prior to diagnosis, potentially delaying critical treatment."
These findings underscore the urgent need for better risk stratification methods to guide appropriate clinical decision-making for patients with pulmonary nodules.
Real-World Evidence from Safety-Net Hospital
In a complementary presentation scheduled for May 19 at the American Thoracic Society (ATS) 2025 International Conference in San Francisco, Dr. Sonu Sahni, Director of Lung Cancer Screening at Wyckoff Heights Medical Center in New York, will present findings from an independent, single-center observational study.
The research, titled "Utilization of Proteomic Testing in Pulmonary Nodule Risk Stratification at a Safety-Net Hospital: An Observational Study," examined outcomes for 103 patients who received Nodify Lung testing in real-world clinical practice. The results demonstrate how Biodesix's proteomic testing can be effectively integrated into lung cancer screening programs to guide management decisions through 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."
Addressing an Unmet Clinical Need
The management of pulmonary nodules represents a significant clinical challenge. When nodules are discovered—often incidentally during imaging for unrelated conditions or through lung cancer screening programs—clinicians must determine whether they are benign or malignant and decide on appropriate follow-up.
Traditional risk assessment methods, which rely primarily on nodule characteristics and patient risk factors, have limitations in accurately differentiating between benign and malignant nodules. This can lead to unnecessary invasive procedures for benign nodules or delayed diagnosis for malignant ones.
Biodesix's Nodify Lung® tests use proteomic technology to provide additional biological information that can help clinicians more accurately assess nodule risk and determine the most appropriate management strategy. This approach aims to reduce both over-treatment of benign nodules and under-treatment of malignant ones.
The company's diagnostic portfolio includes tests marketed as Nodify Lung® Nodule Risk Assessment and IQLung™ Cancer Treatment Guidance, designed to support clinical decisions and improve outcomes for patients with lung disease.
As lung cancer screening programs continue to expand nationwide, the need for accurate risk stratification tools becomes increasingly important. Early detection of lung cancer can significantly improve survival rates, but only if followed by appropriate and timely intervention.
The data presented at these prestigious medical conferences adds to the growing evidence supporting the clinical utility of Biodesix's diagnostic tests in addressing this critical healthcare need.
