bioAffinity Technologies’ CyPath® Lung Test Sales Surge 146% in Q1 2026, Driven by Growing Adoption for Early Lung Cancer Detection 1

bioAffinity Technologies Reports 146% Surge in CyPath® Lung Test Unit Sales for Q1 2026

Strong Momentum in Noninvasive Lung Cancer Diagnostic Drives Market Excitement

Key Highlights for Investors

CyPath® Lung test unit sales soared 146% year-over-year in Q1 2026, surpassing internal company projections and reflecting rapidly accelerating physician adoption and broader clinical integration.
The addressable U.S. market for pulmonary nodule management and lung cancer survivor surveillance is estimated at \$3.58 billion. CyPath® Lung is targeting both newly discovered nodules and post-treatment monitoring.
CyPath® Lung uses advanced flow cytometry combined with artificial intelligence (AI) to deliver actionable, noninvasive diagnostic results, supporting physicians in lung cancer risk assessment, nodule management, and surveillance.
Real-world evidence and case studies show the potential of CyPath® Lung to detect lung cancer at Stage 1A—the most treatable stage—and to reduce unnecessary invasive procedures when malignancy is unlikely.
Revenue from CyPath® Lung increased 87% year-over-year in 2025, and test units sold grew 99% compared to 2024, according to audited results. The latest preliminary Q1 2026 results further confirm accelerating growth.
The company is executing a focused commercial strategy, including expanding physician sites, encouraging peer-to-peer pulmonologist education, and integrating CyPath® Lung into everyday clinical workflows.
bioAffinity Technologies is advancing a large-scale, longitudinal clinical study to generate additional validation data, broadening the use of CyPath® Lung for both new nodule assessment and post-treatment lung cancer survivor monitoring.
The R&D pipeline includes diagnostic tests for asthma and COPD, aiming to support personalized treatment and expand the platform’s commercial potential.
CyPath® Lung demonstrated 92% sensitivity, 87% specificity, and 88% accuracy for early-stage lung cancer detection in high-risk patients with small nodules, though broader real-world results may vary.

Details and Strategic Insights

bioAffinity Technologies (Nasdaq: BIAF; BIAFW) has delivered a highly positive update for shareholders: in Q1 2026, sales of its flagship CyPath® Lung test surged by 146% compared to the same period in the prior year, outpacing internal forecasts. This growth was attributed to increasing recognition among physicians of the test’s unique value in aiding clinical decision-making and improving patient outcomes, particularly in the early detection of lung cancer.

The noninvasive CyPath® Lung test is designed to support crucial junctures in lung cancer risk assessment and nodule management pathways. It leverages flow cytometry and proprietary AI algorithms to analyze sputum samples, providing a binary result (“likely” or “unlikely” malignancy) to guide next steps. This approach can help detect lung cancer at its earliest, most treatable stage (Stage 1A), and reduce unnecessary, risky, and expensive invasive procedures when the test result is negative.

Market Opportunity and Growth Drivers

The U.S. market for indeterminate pulmonary nodule management and surveillance of lung cancer survivors is substantial and growing. The number of patients with incidentally identified nodules or those discovered through increased lung cancer screening is projected to rise 62%, from 2.9 million in 2025 to 4.7 million in 2030.
The population of lung cancer survivors is also set to increase sharply, from 680,000 in 2025 to over 871,000 by 2030.
If CyPath® Lung captures just 10% of both markets, annual sales could reach \$358 million, rising above \$560 million within five years, based on a forecasted 10% compound annual growth rate driven by expanded screening and improved guideline adherence.

Commercial Execution and Expansion

The company’s growth strategy is multi-faceted, focusing on scaling up physician adoption through:

Expanding the number of ordering physician sites
Promoting peer-to-peer education among pulmonologists
Integrating CyPath® Lung into standard clinical workflows for both risk assessment and nodule management

Audited financials show CyPath® Lung revenue rose 87% year-over-year in 2025, with units sold up 99% versus 2024. These milestones validate the initial commercialization phase and position the company for continued expansion.

Ongoing and Future Initiatives

bioAffinity is conducting a large-scale, longitudinal clinical study to further validate CyPath® Lung and expand its clinical indications.
The test is also being positioned for broader use in monitoring lung cancer survivors post-treatment.
The R&D pipeline includes new diagnostics for asthma and COPD, targeting the growing trend toward personalized medicine using targeted therapies.

Clinical Performance

In high-risk patients with small indeterminate lung nodules (<20mm), CyPath® Lung has shown 92% sensitivity, 87% specificity, and 88% accuracy for early-stage lung cancer detection. The test is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies, and is overseen under CLIA regulations.

Potential Share Price Impact and Key Considerations

The significant and accelerating growth in unit sales—well above internal projections—and the robust market opportunity are likely to be seen positively by investors and could drive share price appreciation.
The company’s focus on commercial execution and expansion, combined with validated clinical performance and a strong R&D pipeline, strengthens its long-term value proposition.
However, investors should note the preliminary and unaudited nature of Q1 2026 data, the company’s current reliance on a single commercial product, regulatory risks around LDTs, and the need for ongoing clinical validation and market acceptance. The company also faces competition from other diagnostic technologies and will require additional capital to fund its growth plans.

About bioAffinity Technologies

bioAffinity Technologies, Inc. is focused on noninvasive diagnostics and early detection of lung cancer and other lung diseases. Its lead product, CyPath® Lung, is a noninvasive test for early-stage lung cancer with high demonstrated sensitivity, specificity, and accuracy. The company is also developing diagnostics for asthma and COPD, aiming to support the adoption of targeted therapies.

For more information, investors can visit bioaffinitytech.com.

Forward-Looking Statements Disclaimer

Disclaimer: This article contains forward-looking statements based on current expectations, projections, and assumptions about future events. Actual results may differ materially due to risks and uncertainties including market acceptance, regulatory environment, competition, the outcome of clinical studies, and the company’s ability to fund operations. Investors are advised not to place undue reliance on forward-looking statements and to review the company’s filings with the SEC for a full discussion of risks. This article does not constitute investment advice.