bioAffinity Technologies, Inc. reported a consolidated revenue of approximately $6.2 million for the fiscal year ended December 31, 2025, a decrease of about 34% from $9.4 million in 2024. This decline is attributed to the company's strategic decision to discontinue unprofitable pathology services and focus on operational efficiency, which, while reducing short-term revenue, is expected to enhance long-term growth potential for its flagship product, CyPath® Lung. The revenue from CyPath® Lung testing, however, saw a significant increase of approximately 87%, rising to $963,000 from $516,000 in the previous year, driven by a 99% increase in the number of tests delivered, totaling over 1,200.
The company raised approximately $16.9 million in gross proceeds from equity transactions during the year, which is crucial for funding ongoing operations and development efforts. Despite these efforts, bioAffinity reported a net loss of $14.9 million for 2025, compared to a net loss of $9.0 million in 2024. The increase in losses is primarily due to higher operational costs associated with expanding its clinical development and research activities, particularly in preparation for its pivotal clinical trial for CyPath® Lung.
In terms of operational developments, bioAffinity has initiated a longitudinal clinical study to further validate the effectiveness of CyPath® Lung, enrolling its first patient in March 2026. This trial aims to assess the test's performance in detecting early-stage lung cancer in high-risk patients. Additionally, the company has expanded its research collaborations with military medical centers to explore the utility of CyPath® Lung in analyzing sputum samples obtained through bronchoscopy, which could enhance the test's application in clinical settings.
The company currently employs 57 individuals, with a significant portion dedicated to research and development. bioAffinity's management emphasizes the importance of attracting and retaining skilled personnel to support its growth strategy. The company is also preparing to relocate its research operations from the University of Texas at San Antonio to privately owned laboratory space, a move expected to facilitate its expansion plans.
Looking ahead, bioAffinity Technologies aims to continue scaling its operations and increasing the adoption of CyPath® Lung while seeking strategic partnerships to advance its therapeutic discoveries. However, the company acknowledges the need for additional capital to sustain its operations and fund future growth initiatives, with management indicating that without further financing, it may face challenges in continuing as a going concern beyond mid-2026.
About bioAffinity Technologies, Inc.
bioAffinity Technologies develops noninvasive diagnostic tests for early lung cancer detection using flow cytometry and AI-driven analysis of sputum samples. Its flagship product, CyPath Lung, aims to improve diagnostic accuracy, reduce unnecessary invasive procedures, and support timely treatment. The company also explores therapeutic discoveries and operates a clinical laboratory, serving high-risk populations and healthcare providers worldwide in the growing cancer diagnostics market.
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