Business Wire·Apr 1, 2026, 8:00 AM ET

bioAffinity Technologies' CyPath® Lung Test Unit Sales Surged 146% Year-Over-Year in Q1 2026

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bioAffinity Technologies announced that CyPath® Lung unit sales in Q1 2026 exceeded projections with 146% year-over-year growth compared to Q1 2025.
The noninvasive diagnostic test addresses a U.S. addressable market of $3.58 billion for pulmonary nodule management & lung cancer survivor surveillance.
U.S. indeterminate pulmonary nodule cases are projected to rise 62% from 2.9 million in 2025 to 4.7 million in 2030, while lung cancer survivors are expected to increase to over 871,000 by 2030.
CyPath® Lung utilizes flow cytometry & AI technology to provide binary results indicating "likely" or "unlikely" malignancy to support clinical decision-making.
Real-world data suggests the test can detect Stage 1A lung cancer when most treatable & helps avoid unnecessary invasive procedures for negative results.
Audited 2025 financials showed an 87% increase in revenue & a 99% increase in test units sold compared to 2024.
Commercial growth strategies include expanding ordering physician sites, increasing peer-to-peer education among pulmonologists, & integrating the test into clinical workflows.
The company is advancing a large-scale longitudinal clinical study & an R&D pipeline for asthma & COPD diagnostics.
CyPath® Lung demonstrated 92% sensitivity, 87% specificity, & 88% accuracy in detecting lung cancer in high-risk patients with nodules under 20mm.
The test is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies, under CLIA regulations.