On September 9, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, reported another compelling case study in which its flagship product, CyPath Lung, identified cancer in a patient with an incidental finding of ground-glass lung nodules (Press release, BioAffinity Technologies, SEP 9, 2025, View Source [SID1234655874]).
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Ground-glass nodules appear in imaging as hazy gray areas distinct from solid nodules. Clinicians often find them challenging to assess because they can remain stable for many years, often mimic benign lesions caused by inflammation or fibrosis, and typically do not light up on PET scans.
"Society guidelines for ground-glass nodules recommend two to five years of watchful waiting with serial CT scans. Obviously, this can put both patients and their doctors in an uncomfortable position of balancing uncertainty against the risks of delayed diagnosis," said Gordon Downie, MD, PhD, bioAffinity Technologies’ Chief Medical Officer. "Adding CyPath Lung to the traditional standard of care can provide actionable results that move beyond watchful waiting to timely, potentially life-saving treatment."
The patient, a 66-year-old former smoker, underwent a CT scan for abdominal pain, suspecting kidney stones. The scan incidentally captured a ground-glass nodule in her lung, and a subsequent CT scan of the chest found multiple ground-glass nodules, the largest 13 mm in length. Because of her smoking history, she was referred to a lung clinic for evaluation and risk stratification. Her physician ordered the CyPath Lung test, which returned a "likely malignant" result. Based on the positive CyPath Lung test, the care team proceeded with robotic bronchoscopy. Pathology confirmed lung cancer, and the patient was referred for surgical treatment.
"This case provides another real-world example of CyPath Lung’s value in the evaluation of both solid and sub-solid lung nodules by providing actionable information in real time that can help direct next steps in care, reduce uncertainty and improve patient outcomes," bioAffinity Technologies President and CEO Maria Zannes said. "CyPath Lung has the potential to significantly reduce the mystery of sub-solid, or ground-glass, nodules when they show up on imaging, and both patient and physician are reluctant to delay diagnosis."
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.