SAN ANTONIO — A new case study released by bioAffinity Technologies highlights the diagnostic value of its CyPath® Lung test, which successfully identified a Stage 1A neuroendocrine tumor in a patient whose condition had gone undetected by conventional diagnostic tools including PET scans, bronchoscopies, and tumor marker tests.
The patient, an 80-year-old former smoker with mild pulmonary issues, had a 13mm lung nodule initially flagged during a low-dose CT (LDCT) scan in October 2023. Follow-up evaluations, including a PET scan and multiple bronchoscopies, suggested inflammation rather than malignancy. Despite persistent symptoms and stable imaging, traditional risk models estimated only a 16% likelihood of cancer, leading clinicians to adopt a wait-and-see approach.
It wasn’t until early 2025—following a new respiratory infection and growth of the lung nodule—that the patient’s physician ordered the CyPath® Lung test. The noninvasive sputum-based test returned a high cancer likelihood score of 0.72. Based on that result, the patient underwent a robotic wedge resection in June 2025, which confirmed the presence of a Stage 1A neuroendocrine tumor.
“We believe that this patient’s experience demonstrates the high added value that CyPath® Lung brings to the diagnostic pathway,” said Dr. Gordon Downie, Chief Medical Officer at bioAffinity Technologies. “Multiple procedures and diagnostic tools were inconclusive, failing to identify the 13mm lung nodule as cancer. The CyPath® Lung test clarified the next steps and enabled timely surgical intervention.”
Maria Zannes, President and CEO of bioAffinity Technologies, emphasized the broader implications of the case. “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,” she said.
The company said this case exemplifies the potential for CyPath® Lung to serve as a critical tool in detecting hard-to-identify cancers early, particularly in patients who may not meet traditional high-risk criteria.
