Increased adoption of flow cytometry and artificial intelligence tools helps clinicians manage the rising number of indeterminate pulmonary nodules.
bioAffinity Technologies announced that unit sales for its CyPath Lung diagnostic increased 146% in the first quarter of 2026 compared to the first quarter of 2025, according to preliminary unaudited data.
The sales growth reflects an expansion of clinical use for the noninvasive lung cancer diagnostic. The test utilizes flow cytometry and artificial intelligence (AI) to analyze patient samples, providing a binary result of “likely” or “unlikely” malignancy to assist in clinical decision-making.
“The stronger than expected unit growth in the first quarter of 2026 reflects growing recognition of the value that CyPath Lung brings to clinical decision-making and patient outcomes,” says Maria Zannes, president and CEO of bioAffinity Technologies, in a release. “Physicians are seeking more accurate, noninvasive tools to assess lung cancer risk and detect disease at its earliest, most treatable stage. CyPath Lung is designed to address a critical gap in the diagnostic pathway by supporting lung cancer risk assessment, pulmonary nodule management, and post-treatment surveillance.”
The rising number of indeterminate pulmonary nodules identified through lung cancer screening and incidental imaging drives the demand for such diagnostics. According to estimates from the US Preventive Services Task Force, the number of detected nodules in the US is projected to grow 62% from 2.9 million in 2025 to 4.7 million in 2030.
The flow cytometry technology is designed to help detect lung cancer at Stage 1A and potentially allow patients to avoid unnecessary invasive procedures when test results are negative. The company reports that the current US addressable market for pulmonary nodule management and surveillance of lung cancer survivors is approximately $3.58 billion.
In 2025, CyPath Lung revenue increased 87% year-over-year, while test units sold grew 99% compared to 2024. The company is currently conducting a large-scale longitudinal clinical study to generate additional validation data. Its research pipeline also includes diagnostic tests for asthma and chronic obstructive pulmonary disease to guide personalized treatment.
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