bioAffinity Technologies plans to promote its CyPath Lung test at the Lung Cancer Initiative of North Carolina’s “Battle of the Blues” on Nov. 5, during National Lung Cancer Awareness Month. The event will bring together patients, physicians and other healthcare providers to discuss lung cancer research, diagnostics and treatment.
The announcement focuses on awareness and education around early detection. It does not announce a new clinical study, regulatory clearance or commercial agreement.
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CyPath Lung’s intended use: The noninvasive test analyzes cells in a patient’s sputum using flow cytometry, artificial intelligence and a proprietary fluorescent compound. It returns a “Likely” or “Unlikely” result for malignancy to help physicians assess risk and decide on follow-up for patients with pulmonary nodules.
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Clinical performance cited by the company: In a published trial involving high-risk patients with small, indeterminate lung nodules under 20 millimeters, CyPath Lung showed 92% sensitivity, 87% specificity, 88% accuracy and a 99% negative predictive value. The company says the high negative predictive value may help physicians assess whether invasive procedures are warranted.
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Early-stage detection claim: bioAffinity says the test has detected lung cancer as early as Stage 1A in multiple case studies, when treatment may be more effective. That statement refers to case studies, not a new trial announced with this event.
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Use limitations: CyPath Lung is marketed as a laboratory-developed test and is not intended to serve as a standalone diagnostic tool. Results should be considered alongside a patient’s overall clinical evaluation.
The announcement is primarily a product-awareness effort, rather than a change in bioAffinity’s operations, financing or strategy.