On April 14, 2026 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing noninvasive diagnostics for lung cancer and other lung diseases, reported a new clinical case study illustrating how CyPath Lung, the Company’s noninvasive sputum-based diagnostic test, helped determine next steps for a high-risk patient with a suspicious pulmonary nodule where imaging and risk models suggested a high likelihood of cancer, but the physician suspected possible inflammation.
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The patient, a 70-year-old female with a 50 pack-year smoking history and smoking-related emphysema, presented with increased symptoms including cough, sputum production and shortness of breath. A low-dose CT scan identified a suspicious 30-millimeter (mm) lesion in the lower right lung with nearby enlarged lymph nodes, findings that can be associated with lung cancer. PET imaging suggested a high likelihood of malignancy. Lung cancer risk calculators estimated the probability of cancer as high on the Mayo and Herder models and intermediate on the Brock model.
"In this case, imaging findings and risk calculators suggested a very high probability of lung cancer, and we scheduled her for biopsy," said Daya Nadarajah, MD, the treating pulmonologist. "I routinely use CyPath Lung in my practice and ordered the test for her. She received a negative result, ‘Unlikely Malignancy,’ which prompted another scan before we moved forward with the biopsy."
A follow-up CT scan showed that the concerning 30-mm nodule had completely resolved, confirming the physician’s acumen that the abnormality was due to a reversible inflammatory process rather than lung cancer.
"In patients with underlying lung disease, like emphysema, or other comorbidities like cardiovascular disease, biopsy can carry significant risks. Physicians must weigh the risks against the potential benefits," said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies. "Adding CyPath Lung to the diagnostic pathway for indeterminate nodules provides additional objective data that can be very valuable when assessing patients with complicating health conditions. In this patient’s case, CyPath Lung supported additional imaging before biopsy which resulted in saving the patient from a risky, costly and unnecessary procedure."
This case highlights how CyPath Lung can assist physicians with pulmonary nodule management by helping physicians confidently defer unnecessary – and often risky – invasive procedures. This case study is illustrative of a single patient experience and does not establish generalized clinical utility.
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. In a clinical trial of high-risk patients, CyPath Lung 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. CyPath Lung is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.
(Press release, BioAffinity Technologies, APR 14, 2026, View Source [SID1234664349])