bioAffinity Technologies reports 146% jump in CyPath Lung test sales

bioAffinity Technologies Inc. (NASDAQ: BIAF) reported that unit sales of its CyPath Lung diagnostic test increased 146% in the first quarter of 2026 compared to the same period in 2025, according to preliminary unaudited data released by the company.

The San Antonio-based biotechnology company said the growth exceeded internal projections and reflects increased physician adoption of the noninvasive lung cancer diagnostic test. Chief Executive Maria Zannes attributed the performance to growing recognition of the test's value in clinical decision-making.

CyPath Lung uses flow cytometry and artificial intelligence to analyze patient sputum samples and provide a binary result indicating likely or unlikely malignancy. The company markets it as a Laboratory Developed Test through its subsidiary Precision Pathology Laboratory Services.

bioAffinity Technologies reported that CyPath Lung revenue increased 87% year-over-year in 2025, while test units sold grew 99% compared to 2024, based on audited financial results.

The company estimates the U.S. addressable market for pulmonary nodule management at $3.58 billion. According to U.S. Preventive Services Task Force estimates cited by the company, indeterminate pulmonary nodules detected through screening and incidental imaging are projected to grow from 2.9 million in 2025 to 4.7 million in 2030.

The test demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in high-risk patients with small indeterminate lung nodules less than 20 millimeters, according to clinical data provided by the company.

bioAffinity Technologies is conducting a large-scale longitudinal clinical study to generate additional validation data for CyPath Lung and is developing diagnostic tests for asthma and chronic obstructive pulmonary disease.

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