Noninvasive Sputum Test Detects Early Lung Cancer

Early detection remains critical for improving outcomes in lung cancer, yet clinicians increasingly encounter indeterminate pulmonary nodules found incidentally or through screening, complicating decision-making. Current efforts focus on refining risk assessment and integrating adjunctive diagnostics that can reduce unnecessary invasive procedures when disease is most treatable. A noninvasive, sputum-based test now applies flow cytometry and AI to interrogate the lung microenvironment for malignancy and will be highlighted at a dedicated clinical symposium.

bioAffinity Technologies’ CyPath Lung is a noninvasive sputum-based diagnostic that uses advanced flow cytometry and proprietary AI to identify cancer and cancer-related cell populations within the lung microenvironment. The assay incorporates a fluorescent porphyrin that is preferentially taken up by malignant and cancer-associated cells, enabling analysis from expectorated sputum. Clinical data and case studies have shown potential to detect cancer as early as Stage 1A, while a negative result may help avert unnecessary invasive procedures.

In high-risk patients with small indeterminate lung nodules under 20 millimeters, the test demonstrated 92% sensitivity, 87% specificity, and 88% accuracy for lung cancer detection. The assay is described as balanced, with high sensitivity and specificity that support decision-making regardless of nodule size or prior cancer history. Initially designed to assist evaluation of indeterminate nodules identified through screening or incidental imaging, it can also be used to monitor lung cancer survivors for recurrence. Results may vary in broader clinical use.

CyPath Lung will be featured at Cleveland Clinic’s invitation-only “Advances in Early Lung Cancer Detection” symposium in Cleveland, Ohio, on April 16, 2026. The seventh annual meeting convenes physicians, advocacy organizations, researchers, and industry to accelerate development and implementation of technologies that find lung cancer at its earliest stages. Gordon Downie, MD, PhD, Chief Medical Officer at bioAffinity Technologies, will join a three-person panel on lung nodule management to discuss the test’s clinical use. This marks the company’s seventh invitation to present at the symposium.

“As the number of indeterminate pulmonary nodules discovered incidentally and by lung screening continues to grow, so does the accompanying need for noninvasive, scalable diagnostic solutions. CyPath® Lung directly addresses many of the issues that will be discussed at the Cleveland Clinic’s symposium," said Dr. Gordon Downie.

"Using our sputum-based diagnostic as an adjunct to the current standard of care for newly discovered non-calcified pulmonary nodules helps guide difficult clinical discussions, accelerates diagnosis and prevents unnecessary invasive procedures. Adding CyPath® Lung to the diagnostic pathway provides actionable results to physicians, eases anxiety for patients, and can reduce costs to the healthcare system,” added Dr. Downie.

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