BIAFW · bioAffinity Technologies, Inc.

bioAffinity Technologies reported preliminary unaudited data showing CyPath® Lung unit sales surged 146% year-over-year in Q1 2026, surpassing internal projections. This strong performance builds on 2025 audited results where revenue grew 87% and test units increased 99% compared to 2024, signaling successful execution of the company's commercialization strategy. Key drivers include expansion of ordering physician sites, peer-to-peer education among pulmonologists, and integration into clinical workflows for lung cancer risk assessment and nodule management. CEO Maria Zannes highlighted growing recognition of CyPath® Lung's value in clinical decision-making, particularly for high-risk patients with indeterminate pulmonary nodules. The test's flow cytometry+AI technology delivers binary 'likely' or 'unlikely' malignancy results, with real-world cases demonstrating potential to identify Stage 1A lung cancer and reduce unnecessary invasive procedures. Addressing a $3.58 billion U.S. market opportunity in pulmonary nodule management and surveillance for over 680,000 lung cancer survivors, capturing just 10% could yield $358 million in sales, scaling to over $560 million by 2030 amid projected 62% growth in indeterminate nodules to 4.7 million. The company is advancing a large-scale longitudinal study, broader survivor monitoring, and an R&D pipeline for asthma/COPD diagnostics to sustain momentum. While data is preliminary and unaudited, these results underscore accelerating adoption and position CyPath® Lung as a core growth driver in noninvasive early cancer detection.