DENVER, Colo. (247marketnews.com) -- bioAffinity Technologies (NASDAQ:BIAF) is pushing CyPath Lung beyond its initial early-detection opportunity and into a potentially much larger part of the lung-cancer care continuum: surveillance after curative-intent treatment. The company says more than 680,000 Americans were living with a history of lung cancer as of January 1, 2025, creating a substantial population that requires ongoing monitoring. bioAffinity believes its noninvasive sputum-based test could complement imaging when physicians encounter new or changing pulmonary nodules where CT scans cannot readily distinguish recurrent cancer from a new primary cancer or benign treatment-related changes. The American Cancer Society confirms that lung cancer represents one of the major survivor populations in the United States, with roughly 680,000 people living with a history of the disease based on its 2025 prevalence estimates.
The commercial pitch is straightforward: more information without immediately moving to an invasive procedure. Texas Oncology physician Vijay Gunuganti, MD, said, “Imaging alone cannot tell us if it is recurrent cancer, a new cancer, or benign post-treatment changes including fibrosis, scarring, and treatment-related inflammation.” He added that CyPath Lung’s binary “unlikely or likely malignancy” result could help physicians determine which patients warrant closer investigation. The company is careful to note that its published performance figures, 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value, come from the detection setting and have not been separately validated for post-treatment surveillance. That distinction is critical for investors evaluating the size of the opportunity.
The announcement also lands amid accelerating commercial activity for BIAF. In August, bioAffinity reported that CyPath Lung test volume jumped 216% year over year in the second quarter, while the company continued expanding physician adoption and developing its longitudinal clinical program. In July, it published a clinical framework specifically addressing pulmonary-nodule risk stratification and surveillance of lung-cancer survivors, while an August distribution agreement with AvMEDICAL expanded its reach into federal healthcare markets. The company is also conducting a longitudinal study designed to enroll up to 2,000 patients across 17 VA, military, academic and private medical centers, providing another potential source of validation for broader adoption.
For bioAffinity, the developing story is therefore increasingly about converting clinical validation into a repeatable diagnostic business. CEO Maria Zannes said, “As our commercial experience with CyPath Lung grows, we are examining how our noninvasive approach may provide value throughout the patient's lung cancer journey.” The company has also recently raised capital and completed a 1-for-15 reverse stock split, while its Nasdaq listing remains subject to an appeal following a compliance issue, important risks that sit alongside the commercial opportunity.
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