SAN ANTONIO, July 27, 2026
bioAffinity Technologies, Inc. announced the publication of a comprehensive clinical review and white paper introducing a practical framework for integrating its CyPath® Lung test into the evaluation of pulmonary nodules and the surveillance of patients at risk for lung cancer. Authored by Chief Medical Officer Gordon H. Downie, MD, PhD, the publication outlines specialty-specific clinical pathways for primary care physicians, pulmonologists, and oncologists to incorporate the noninvasive diagnostic test into routine clinical decision-making. The framework addresses the increasing demand for more effective pulmonary nodule risk stratification as lung cancer screening programs, incidental imaging findings, and artificial intelligence (AI) technologies identify growing numbers of patients requiring evaluation. According to the company, the publication is based on three years of commercial experience with CyPath® Lung and is intended to complement existing imaging methods and clinical assessment rather than replace current diagnostic guidelines.
CyPath Lung Enhances Clinical Decision-Making Through Lung Microenvironment Analysis
The newly published framework highlights the unique role of CyPath® Lung in analyzing the lung microenvironment using patient sputum samples, offering physicians biological information that cannot be obtained through conventional blood-based diagnostic tests. The publication explains that CyPath® Lung combines proprietary flow cytometry, fluorescent porphyrin labeling, and artificial intelligence analysis to identify malignant and cancer-associated cells directly from the lungs. This approach provides objective data that can help physicians better distinguish between benign and malignant pulmonary nodules, particularly in cases where imaging findings or predictive models produce conflicting or uncertain results. The white paper also presents several real-world clinical case studies demonstrating how CyPath® Lung contributed additional diagnostic confidence, enabling physicians to determine whether patients required invasive procedures such as biopsies or could instead be safely monitored through ongoing surveillance.
Framework Recommends Specialty-Specific Clinical Pathways
The publication proposes dedicated clinical pathways tailored to different healthcare settings where pulmonary nodule management is becoming increasingly complex. These include primary care practices managing incidentally detected lung nodules, pulmonary nodule clinics and interventional pulmonology programs evaluating patients for biopsy, and oncology practices monitoring cancer survivors for recurrence. Company President and Chief Executive Officer Maria Zannes stated that the rapid increase in pulmonary nodule detection has created a significant need for improved risk stratification tools, and emphasized that CyPath® Lung provides physicians with clinically meaningful information that complements radiographic imaging and physician judgment. Dr. Downie further noted that every patient presents a unique clinical picture and that the goal of the framework is to provide clinicians with an additional source of objective evidence when traditional diagnostic approaches alone are insufficient to support confident treatment decisions.
Advertisement
CyPath Lung Continues to Strengthen Early Lung Cancer Detection
The publication reinforces bioAffinity Technologies’ focus on advancing early lung cancer detection through innovative noninvasive diagnostics. CyPath® Lung is currently marketed as a Laboratory Developed Test (LDT) and has demonstrated strong clinical performance in previously published studies involving high-risk patients with small indeterminate pulmonary nodules. Clinical data cited by the company showed 92% sensitivity, 87% specificity, 88% overall accuracy, and a 99% negative predictive value, providing physicians with increased confidence in ruling out lung cancer while potentially reducing unnecessary invasive procedures and healthcare costs. Although the test is intended to complement—not replace—existing clinical evaluation and imaging, the newly published clinical framework provides a structured roadmap for integrating lung microenvironment analysis into modern diagnostic pathways. As the use of AI-assisted imaging and lung cancer screening continues to expand worldwide, bioAffinity Technologies believes CyPath® Lung can play an increasingly important role in improving patient management and supporting earlier, more accurate detection of lung cancer.
Source: bioAffinity Technologies, press release
