On July 27, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, reported the publication of a comprehensive clinical review and white paper authored by Chief Medical Officer Gordon H. Downie, MD, PhD, that presents a practical clinical framework for incorporating CyPath Lung into pulmonary nodule evaluation and cancer surveillance.
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Titled "Lung Nodules, Lung Microenvironment, Predictive Models and Clinician Risk Stratification Using CyPath Lung Testing for Early Diagnosis of Lung Cancer," the paper examines the growing clinical challenge of evaluating pulmonary nodules as lung cancer screening expands, incidental findings increase, artificial intelligence identifies even more incidental nodules, and more patients require long-term surveillance following cancer treatment.
"Pulmonary medicine is entering a new era in which clinicians are evaluating more pulmonary nodules than ever before, driving a rapidly growing need for better risk stratification," said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. "Dr. Downie’s white paper demonstrates how CyPath Lung can provide physicians with clinically meaningful information that complements imaging and clinical assessment, helping them make more confident decisions about which patients require invasive procedures and which can be safely monitored."
Drawing on the three years of commercial experience since CyPath Lung entered the market, the publication discusses how the noninvasive test has demonstrated consistent clinical performance in helping physicians stratify malignancy risk and guide patient management, including clinical case studies illustrating how CyPath Lung helped clarify challenging cases in which imaging findings and predictive models alone produced uncertain or conflicting assessments.
The publication explores how advances in understanding the lung microenvironment are reshaping the evaluation of pulmonary nodules. Unlike blood-based diagnostics, CyPath Lung analyzes sputum collected directly from the lungs, providing objective, real-time information from the lung microenvironment to help clarify complex or conflicting clinical presentations.
The paper also reviews the strengths and limitations of existing predictive models and emphasizes that no single diagnostic tool should be used in isolation. Instead, it proposes specialty-specific clinical pathways that integrate CyPath Lung into three care settings:
● Primary care practices managing incidentally discovered pulmonary nodules
● Pulmonary nodule programs and interventional pulmonology practices evaluating patients for biopsy
● Oncology practices conducting surveillance of cancer survivors
"Every patient presents a unique clinical picture," Dr. Downie said. "The objective is not to replace clinician gestalt or existing guidelines, but to provide an additional data point when clinical findings are uncertain or contradictory. CyPath Lung’s interrogation of the lung microenvironment gives physicians information that has not previously been available through traditional imaging or blood-based testing."
The white paper highlights the growing recognition that the lung possesses a unique microenvironment distinct from blood, reflecting local immune responses, inflammation, genetic alterations and tumor biology. By evaluating sputum directly from the lungs, CyPath Lung measures these biologic changes and identifies porphyrin-labeled malignant cells through proprietary flow cytometry and artificial intelligence analysis.
The complete white paper is available at https://bit.ly/cypath-lung-whitepaper3
About CyPath Lung
CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.
(Press release, BioAffinity Technologies, JUL 27, 2026, View Source [SID1234669428])