bioAffinity Technologies Advances CyPath Lung into Post-Treatment Lung Cancer Surveillance
核心洞察
bioAffinity Technologies is expanding its noninvasive CyPath Lung (搜索) test to support surveillance of lung cancer (搜索) patients who have completed curative-intent treatment.
The binary-result test ("unlikely" or "likely malignancy") aims to complement imaging, which often cannot distinguish recurrence from benign post-treatment changes such as fibrosis or scarring.
Published studies report non-small cell lung cancer (搜索) recurrence rates of 20% to 55%, with more than 680,000 Americans living with a prior lung cancer (搜索) diagnosis.
bioAffinity Technologies Inc. (BIAF) announced that it is advancing the application of its CyPath Lung (搜索) test to support surveillance of lung cancer (搜索) patients who have completed curative-intent treatment. The noninvasive test, which has already demonstrated its ability to detect early-stage lung cancer in clinical trials and practice, is being positioned as a complement to imaging in monitoring for recurrence and new cancers.
The move addresses a persistent clinical challenge in lung cancer (搜索) care. Published studies report recurrence rates of 20% to 55% for non-small cell lung cancer (搜索) (NSCLC), depending on stage and treatment. More than 680,000 Americans are living with a prior lung cancer diagnosis, and another 230,000 are expected to be diagnosed in 2026. Current guidelines recommend surveillance imaging every six months for two years following curative treatment, followed by low-dose CT scans.
Addressing a Gap in Post-Treatment Monitoring
Physicians note that imaging alone often cannot distinguish between recurrent cancer, new cancer, or benign post-treatment changes such as fibrosis or scarring. CyPath Lung (搜索) provides a binary result—"unlikely" or "likely malignancy"—that can help guide decisions on whether closer investigation is needed or if continued surveillance is appropriate.
Maria Zannes, President and CEO of bioAffinity Technologies, emphasized that surveillance after treatment has the potential to lead to earlier intervention and improved patient outcomes. She noted that as commercial experience with CyPath Lung (搜索) grows, the company is exploring how its noninvasive approach can provide value throughout the patient's lung cancer (搜索) journey.
Expanding the Diagnostic Platform
The advancement of CyPath Lung (搜索) into post-treatment surveillance highlights bioAffinity's commitment to expanding its diagnostic platform and addressing unmet needs in lung cancer (搜索) care. CyPath Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services (搜索), a subsidiary of bioAffinity Technologies, and is overseen under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services.
The company implemented a 1-for-30 reverse stock split on September 19, 2025. BIAF is currently trading at $8.20, up 80.04%. Separately, bioAffinity announced that President and CEO Maria Zannes will present a corporate update and hold one-on-one investor meetings during the H.C. Wainwright 28th Annual Global Investment Conference, being held September 14-16, 2026.