New Case Study Highlights Ability of bioAffinity Technologies’ CyPath® Lung to Reduce Diagnostic Burden for Patients At Risk for Lung Cancer
bioAffinity Technologies, Inc. a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, today released a new clinical case study in which its CyPath® Lung noninvasive diagnostic test for lung cancer helped determine the appropriate treatment for a 79-year-old female with a suspicious lung finding on a low-dose computed tomography (LDCT) scan.
The patient, a current smoker with a medical history significant for chronic obstructive pulmonary disease (COPD) and coronary heart disease, underwent LDCT screening in June 2025. Imaging revealed a spiculated, or irregularly shaped, nodule about half an inch in size at the bottom of the right lung, near the lining of the lung. Spiculated nodules raise concerns about malignancy due to their uneven, irregular appearance.
Spiculated findings on CT scans often trigger concern and can lead to invasive procedures, particularly in older high-risk patients,” said Daya Nadarajah, MD, the patient’s pulmonologist. “Given this patient’s age, smoking history and comorbidities, we were not comfortable proceeding directly to an invasive procedure. CyPath® Lung gives us objective data to better stratify risk and avoid putting our patients through unnecessary and potentially risky procedures.
The CyPath® Lung test result was negative, indicating an unlikely malignancy in the lung and supporting a conservative management approach that includes annual CT screening. A repeat scan in October 2025 showed that the suspicious finding from the June scan had resolved, and there were no pulmonary nodules in the lungs.
Every suspicious finding is concerning. Even when the probability of malignancy is low, the consequences of missing a cancer are significant,” said Gordon Downie, MD, PhD, bioAffinity Technologies Chief Medical Officer. “Physicians now have a tool in CyPath® Lung that further refines risk and provides valuable reassurance when deciding whether to monitor or escalate care.
Supporting Confident, Noninvasive Management
Based on the reassuring imaging and negative CyPath® Lung result, the patient and her care team agreed to continue with serial annual CT scans as follow-up care. In this case, CyPath® Lung:
- Provided the confidence to defer invasive procedures
- Prevented an unnecessary biopsy
- Put the patient at ease with ongoing surveillance
- Complemented imaging findings in a high-risk individual
About CyPath® Lung
CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.
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