bioAffinity Technologies Initiates New Study for Expanding CyPath Lung Tech

bioAffinity Technologies Inc. is beginning a pilot study with Brooke Army Medical Center (BAMC) to evaluate the company’s proprietary tests (still in development) to identify specific asthma and chronic obstructive pulmonary disease (COPD) inflammatory biomarkers. The study could lead to the development of diagnostic tests for deciphering the most effective treatments and monitoring the drugs’ effectiveness over time.

The research collaboration with BAMC builds on bioAffinity Technologies’ research pipeline, leveraging its proprietary flow cytometry+AI technology to develop precision diagnostics and treatments for common airway diseases by assessing the extent and type of lung inflammation.

“We have made tremendous strides over the last decade in our understanding of the pathophysiology of asthma and COPD,” said John J. Oppenheimer, M,D,, an authority on asthma/COPD diagnosis/treatment and professor at the University of Medicine and Dentistry of New Jersey-Rutgers who also is a bioAffinity Technologies board member. “Emerging tools such as bioAffinity’s cytometry+AI platform will likely accelerate this progress by enabling direct assessment of a patient’s inflammatory milieu within the lung. With this level of resolution, we can better stratify the risk of disease progression and more accurately match the right medicine to the right patient.”

The study will enroll approximately 40 participants in three cohorts: patients with asthma, patients with COPD, and a healthy control group. The objective of the study is to use automated analysis of sputum samples collected from patients with asthma and COPD to identify and measure select immune cell populations and cytokines in sputum that can direct treatment and monitor the therapies’ effectiveness.

Asthma is not a single disease. It includes multiple inflammatory subtypes. In military personnel, asthma is generally not the classic allergic form seen in civilian populations, making diagnosis and treatment more challenging. Service members are exposed to a wide range of environmental, occupational, and deployment-related hazards that can fundamentally alter how asthma presents and progresses.

“Our flow cytometry platform provides a novel, noninvasive way to assess lung inflammation at the cellular level,” bioAffinity Technologies Chief Medical Officer Gordon Downie, M.D., Ph.D., stated. “By identifying a broader panel of inflammatory biomarkers, we hope to help shift asthma and COPD management toward a precision medicine model, where treatment is guided by each patient’s unique inflammatory signature rather than a one-size-fits-all approach. Our technology also has the potential to help physicians monitor treatment response over time, improving patient outcomes.”

The BAMC study aims to determine whether the company’s lung inflammation tests—including flow cytometry and enzyme-linked immunosorbent assay (ELISA) analysis—can help physicians tailor more effective treatment strategies for asthma and COPD. In the military context, a safe, reliable, noninvasive way to assess lung inflammation could positively impact readiness and deployment decisions as well as long-term respiratory health outcomes for service members and veterans.

CyPath Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a clinical trial of high-risk patients, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), administered by the Centers for Medicare & Medicaid Services.

bioAffinity Technologies Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments.