Business Wire·Jul 27, 2026, 8:08 AM ET

bioAffinity Technologies Publishes New Clinical Framework Addressing Growing Market for Pulmonary Nodule Risk Stratification and Early Lung Cancer Detection Using CyPath® Lung

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bioAffinity Technologies, Inc. published a clinical review & white paper authored by Chief Medical Officer Gordon H. Downie, MD, PhD, outlining a framework for integrating CyPath® Lung testing into pulmonary nodule evaluation.
The publication addresses the clinical challenge of evaluating increasing numbers of pulmonary nodules driven by expanded lung cancer screening, AI detection, & long-term survivor surveillance.
CyPath® Lung analyzes sputum directly from the lungs to assess the lung microenvironment, offering objective data distinct from blood-based diagnostics or traditional imaging.
The framework proposes specialty-specific clinical pathways for primary care, pulmonology, & oncology practices to help stratify malignancy risk & guide patient management.
Clinical trial data cited in the release indicates CyPath® Lung achieved 92% sensitivity, 87% specificity, 88% accuracy, & 99% negative predictive value in high-risk patients with nodules under 20 millimeters.
The test utilizes proprietary flow cytometry & artificial intelligence to identify porphyrin-labeled malignant cells within patient sputum.
CyPath® Lung is marketed as a Laboratory Developed Test (LDT) under CLIA regulations & is intended to complement, not replace, existing clinical findings & guidelines.
The complete white paper titled "Lung Nodules, Lung Microenvironment, Predictive Models & Clinician Risk Stratification Using CyPath® Lung Testing for Early Diagnosis of Lung Cancer" is available via a provided link.
Forward-looking statements in the release caution that actual results may differ based on factors such as physician adoption, market demand, & competition from other diagnostic technologies.