On July 23, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for noninvasive, accurate tests for the detection of early-stage cancer, reported a compelling new case study in which CyPath Lung identified a Stage 1A neuroendocrine tumor in the patient’s lung after PET scan, bronchoscopies and a serum tumor marker test suggested it was non-cancerous inflammation (Press release, BioAffinity Technologies, JUL 23, 2025, View Source [SID1234654495]).
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"We believe that this patient’s experience demonstrates the high added value that CyPath Lung brings to the diagnostic pathway. Multiple procedures and diagnostic tools were inconclusive, failing to identify the 13mm lung nodule as cancer," said Gordon Downie, MD, PhD, bioAffinity Technologies’ Chief Medical Officer. "So when her CyPath Lung test returned a ‘likely cancer’ result, it clarified appropriate next steps. The end result was surgical removal of a Stage 1A neuroendocrine tumor, a cancer type that can be difficult to detect by imaging and bronchoscopy alone, early enough for potentially life-saving treatment."
The female patient, an 80-year-old former smoker, had less than a 15-pack-year history and quit smoking in 1999. She had stable pulmonary function until a COVID-19 infection left her with asthma symptoms, including wheezing, coughing and shortness of breath, which responded to inhalers. A low dose CT in October 2023 revealed a 13mm nodule in the right lower lobe, but a PET scan showed low metabolic activity and risk models placed the likelihood of malignancy around 16%.
Initial diagnostic workups – including bronchoscopy and serum markers – indicated inflammation or infection without malignancy, and the patient was placed on a surveillance plan with antibiotics and asthma management. Follow-up LDCT scans in January and July 2024 were stable.
In early 2025, a new upper respiratory infection prompted repeat imaging, which showed that the nodule was growing. A second bronchoscopy again returned no evidence of malignancy. Her physician ordered CyPath Lung for further risk assessment. The CyPath Lung test, reported on March 4, 2025, returned a high score of 0.72, indicating the likelihood of cancer.
Based on the CyPath Lung result, the patient was referred for robotic wedge resection in June 2025, and pathology confirmed a Stage 1A neuroendocrine tumor.
"We believe that this case underscores CyPath Lung’s growing importance as an essential adjunct to low-dose CT scans for patients with indeterminate pulmonary nodules when imaging and traditional tools leave questions unanswered," bioAffinity Technologies President and CEO Maria Zannes said.
About CyPath Lung
CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.