The company is evaluating an additional application for CyPath Lung that could complement CT imaging when monitoring lung cancer survivors for recurrence or new primary cancers.
Key Investor Takeaways
- bioAffinity Technologies (NASDAQ:BIAF) is advancing CyPath Lung for potential use in post-treatment lung cancer surveillance, expanding its focus beyond early detection.
- More than 680,000 Americans were living with a prior lung cancer diagnosis as of January 1, 2025, according to figures cited by the company, representing a sizable potential surveillance population.
- CyPath Lung could complement imaging by helping physicians assess whether new or changing pulmonary nodules warrant closer investigation.
- The test has reported 92% sensitivity and 99% negative predictive value in a published trial involving high-risk patients, but those performance figures have not been separately validated for post-treatment surveillance.
- Expanding CyPath Lung across the patient journey may broaden its commercial opportunity, although the surveillance application remains a developing use case rather than an established indication.
Why BIAF Stock Is in Focus
bioAffinity Technologies is advancing the potential use of CyPath Lung as a surveillance tool for patients who have completed curative-intent lung cancer treatment.
The strategy targets a clinical challenge created by the continued risk of recurrence and the difficulty of interpreting post-treatment imaging. New pulmonary nodules can represent recurrent disease, a new primary cancer or benign changes associated with previous treatment.
CyPath Lung is designed to provide additional information alongside imaging through a noninvasive sputum test. Using flow cytometry and proprietary artificial intelligence, the test analyzes cell populations associated with malignancy and produces a binary result indicating whether malignancy is unlikely or likely.
The company cited published studies showing recurrence rates of approximately 20% to 55% for non-small cell lung cancer following treatment, depending on factors including disease stage and therapy.
ASCO guidelines cited by bioAffinity recommend imaging every six months for two years after curative-intent treatment of stage I–III NSCLC, followed by annual low-dose CT scans to monitor for new primary lung cancers.
Why This Matters for Investors
The development potentially expands the addressable role of CyPath Lung from early cancer detection into ongoing patient surveillance.
For bioAffinity, that could create an opportunity to position the test at multiple stages of lung cancer care rather than primarily around initial detection. The company says more than 680,000 Americans were living with a history of lung cancer at the beginning of 2025, while another 230,000 patients are estimated to be diagnosed in 2026.
The recurring nature of surveillance is also strategically relevant. Patients treated with curative intent undergo continued imaging, creating repeated clinical decision points where additional information about suspicious nodules may be useful.
However, investors should distinguish CyPath Lung’s existing detection data from its proposed surveillance application. In a published clinical trial involving high-risk patients with small indeterminate nodules, the test demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value.
Those results relate specifically to lung cancer detection and have not been independently validated for post-treatment surveillance. Establishing evidence for the new application may therefore be an important step in determining its broader clinical and commercial potential.
What to Watch Next
Investors may watch for clinical validation specifically evaluating CyPath Lung in lung cancer survivors undergoing post-treatment surveillance.
Further evidence showing how the test performs alongside CT imaging in distinguishing malignancy risk from treatment-related changes could help clarify the potential value of this expanded application.
Commercial adoption will also be worth monitoring as bioAffinity builds on three years of experience with CyPath Lung and evaluates opportunities to use the test across more stages of the lung cancer patient journey.