bioAffinity Technologies, Inc.

bioAffinity Technologies, Inc. is a biotechnology company headquartered in San Antonio, Texas, focused on developing non-invasive diagnostic tests and targeted cancer therapeutics. The company's core mission is to address the urgent need for early-stage cancer diagnosis and treatment, aiming to improve patient outcomes through accurate detection and advanced therapies.

The company's primary product is CyPath® Lung, a non-invasive diagnostic test designed for the early detection of lung cancer. This test utilizes advanced flow cytometry and proprietary artificial intelligence (AI) to analyze cell populations in sputum samples, identifying characteristics indicative of malignancy. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) through Precision Pathology Laboratory Services, a wholly-owned subsidiary. bioAffinity Technologies is also expanding its platform to develop diagnostic tests for other lung diseases, including asthma and chronic obstructive pulmonary disease (COPD).

Led by President and CEO Maria Zannes, bioAffinity Technologies has reported significant commercial progress. The company announced record revenue and unit sales for CyPath® Lung in 2025, with unit sales increasing by 99% year-over-year, and a 146% surge in Q1 2026 unit sales compared to the previous year. In March 2026, bioAffinity Technologies initiated a large-scale, longitudinal clinical study for CyPath® Lung. Additionally, the company launched a pilot study in April 2026 with Brooke Army Medical Center to evaluate new diagnostic tests for asthma and COPD, further solidifying its position in the expanding early-detection diagnostics market.

Latest updates

bioAffinity Expands Lung Disease Diagnostics with Military Study

Event summary

  • bioAffinity Technologies is collaborating with Brooke Army Medical Center (BAMC) on a pilot study.
  • The study will evaluate the company’s CyPath® Lung technology for diagnosing and treating asthma and COPD.
  • Approximately 40 participants across three cohorts (asthma, COPD, healthy control) will be enrolled.
  • The research leverages bioAffinity’s flow cytometry+AI platform to identify inflammatory biomarkers in sputum samples.
  • The study aims to move asthma and COPD management toward a precision medicine model.

The big picture

bioAffinity is attempting to expand the application of its CyPath® Lung technology beyond lung cancer diagnostics into the large and underserved market for respiratory disease management. The collaboration with BAMC highlights the unique diagnostic challenges within military populations, where asthma and COPD often present differently than in civilian settings. Success in this study could unlock a pathway to precision medicine approaches for these conditions, a growing trend in healthcare.

What we're watching

Clinical Efficacy
The study's results will determine if CyPath® Lung can reliably identify inflammatory biomarkers and guide treatment decisions, a critical step for commercial viability.
Regulatory Pathway
The evolving regulatory framework for Laboratory Developed Tests (LDTs) and potential FDA oversight will significantly impact bioAffinity’s ability to market and scale its diagnostic tests.
Military Adoption
The success of this BAMC collaboration could pave the way for broader adoption of bioAffinity’s technology within the military healthcare system, potentially creating a significant revenue stream.
CID: 3650