San Antonio — bioAffinity Technologies has published a clinical review outlining how its CyPath Lung test could be incorporated into pulmonary nodule evaluation, early lung cancer detection and post-treatment surveillance.
The white paper, authored by Chief Medical Officer Gordon H. Downie, M.D., Ph.D., provides separate clinical pathways for primary care physicians, pulmonologists and oncology practices.
The publication addresses the growing number of pulmonary nodules detected through expanded lung cancer screening, incidental imaging findings and artificial intelligence-assisted image analysis. It also examines the need for continued monitoring of patients who have previously been treated for cancer.
“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.”
CyPath Lung is a noninvasive laboratory-developed test that analyzes sputum collected directly from the lungs. The test uses flow cytometry and proprietary artificial intelligence to identify cellular patterns associated with malignancy.
According to bioAffinity, examining sputum can provide information about local immune responses, inflammation, genetic changes and tumor biology within the lung microenvironment that may not be captured by imaging or blood-based tests.
The review draws on three years of commercial use and includes clinical case studies in which CyPath Lung was used to assess patients whose imaging findings and predictive risk models produced uncertain or conflicting results.
The proposed framework covers primary care practices managing incidentally discovered nodules, pulmonary nodule and interventional pulmonology programs evaluating patients for biopsy, and oncology practices monitoring cancer survivors.
“Every patient presents a unique clinical picture,” 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.”
CyPath Lung incorporates a fluorescent porphyrin that is preferentially absorbed by cancerous and cancer-related cells. The test then uses flow cytometry and AI analysis to identify cell populations associated with lung cancer.
In a previously published clinical study involving high-risk patients with indeterminate lung nodules smaller than 20 millimeters, the test demonstrated 92% sensitivity, 87% specificity, 88% accuracy and a 99% negative predictive value, according to the company.
bioAffinity said the test is intended to supplement imaging, clinical assessments and other diagnostic information rather than serve as a standalone diagnostic tool.
