SAN ANTONIO, September 1, 2026
bioAffinity Technologies, Inc. is advancing the potential use of its noninvasive CyPath® Lung test for surveillance of patients who have completed curative-intent treatment for lung cancer. The company is exploring how the test could complement imaging during follow-up care, particularly when new or changing pulmonary nodules create uncertainty about whether findings represent recurrent cancer, a new primary cancer or benign treatment-related changes. More than 680,000 Americans were living with a history of lung cancer as of January 1, 2025, highlighting a substantial population requiring continued monitoring after treatment..
CyPath Lung Could Complement Imaging
Lung cancer recurrence remains a significant challenge even after patients achieve no evidence of disease following surgery or radiation. Published studies have reported recurrence rates of approximately 20% to 55% for non-small cell lung cancer (NSCLC), depending on disease stage, treatment and other factors. The American Society of Clinical Oncology recommends surveillance imaging every six months for two years following curative-intent treatment of stage I–III NSCLC, followed by annual low-dose CT to monitor for new primary lung cancers. bioAffinity believes CyPath Lung could provide physicians with additional information when imaging identifies pulmonary nodules that are difficult to characterize, potentially helping stratify patients according to malignancy risk and determine who may require closer investigation.
Noninvasive Test Targets Malignancy Risk
CyPath Lung uses advanced flow cytometry, proprietary artificial intelligence and a fluorescent porphyrin to analyze cell populations in patient sputum associated with malignancy. The test provides a binary result indicating whether malignancy is unlikely or likely, which could provide an additional noninvasive assessment alongside imaging and other clinical information. In a previously published clinical trial involving high-risk patients with small indeterminate lung nodules, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value for lung cancer detection. However, these performance results apply to the test’s detection setting and have not been separately validated for post-treatment surveillance, an important distinction as bioAffinity evaluates this potential application.
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bioAffinity Explores Broader Clinical Use
The potential surveillance application builds on approximately three years of commercial experience with CyPath Lung and the company’s efforts to expand the test’s role across the lung cancer care pathway. bioAffinity is evaluating whether the noninvasive technology can provide actionable information when physicians face uncertain or conflicting imaging findings, potentially complementing established CT surveillance rather than replacing it. CyPath Lung is currently marketed as a Laboratory Developed Test (LDT) and is not intended to be used as a standalone diagnostic tool. As more lung cancer patients live longer following curative-intent treatment, the company sees post-treatment surveillance as a potential area where additional noninvasive risk assessment could support earlier investigation and more informed patient management.
Source:bioAffinity Technologies, press relese
