Hong Kong Patent Extends bioAffinity’s CyPath Lung Protection in Asia
bioAffinity Technologies (NASDAQ: BIAF) has received a patent in Hong Kong covering CyPath Lung, its noninvasive lung cancer test. The grant follows a Chinese patent issued in 2025 and gives the company protection in two Asian jurisdictions as it evaluates commercial opportunities outside the U.S.
The Hong Kong patent covers the method CyPath Lung uses to identify lung cancer cells in sputum. The process combines flow cytometry, defined antibodies and the fluorescent porphyrin TCPP.
According to bioAffinity, Asia accounts for approximately 1.6 million new lung cancer diagnoses each year, nearly two-thirds of the global total. The company now holds patents or pending applications in the U.S., Australia, Canada, China, the European Union, Japan, Mexico and Singapore.
99% Negative Predictive Value in Nodules Under 20 Millimeters
CyPath Lung helps physicians assess whether lung nodules found on low-dose CT scans or incidental imaging are likely to be malignant. The test analyzes sputum using flow cytometry, fluorescent markers and proprietary AI.
In a published study of high-risk patients with indeterminate nodules smaller than 20 millimeters, CyPath Lung showed 92% sensitivity, 87% specificity and 88% accuracy. Its negative predictive value reached 99%.
That figure speaks directly to the clinical question the test addresses. A reliable negative result may help physicians determine whether a patient with a suspicious nodule needs further invasive procedures. CyPath Lung is not intended for use as a standalone diagnostic.
Patent Protection Precedes Any Regulatory Path in Asia
bioAffinity currently markets CyPath Lung as a Laboratory Developed Test through its subsidiary, Precision Pathology Laboratory Services. The Hong Kong patent does not represent regulatory clearance or commercial entry into Asia. It does secure the underlying technology in the region with the largest share of lung cancer cases while the company weighs its options there.
CyPath Lung is bioAffinity’s primary commercial asset. The company now holds patent protection for it in both China and Hong Kong.
