About bioAffinity
Technologies
The people behind the science of better futures.
Executive Management
Maria Zannes
J. Michael Edwards, MBA, CPA
William Bauta, PhD
Gordon Downie, MD, PhD
Xavier T. Reveles, MS, CG(ASCP)CM
Dallas J. Coleman
David Elzi, PhD
Timothy P. Zannes, JD
Board of Directors
Steven Girgenti
Peter S. Knight
John J. Oppenheimer, MD
Jamie Platt, PhD
Maria Zannes
Roberto Rios
OUR HISTORY
Rooted in Science, Driven by Purpose
Founded: March 2014
Initial Public Offering: September 2022
CEO: Maria Zannes
bioAffinity Technologies is founded to commercialize promising research orginating at Los Alamos National Laboratory focused on labeling cancer cells for detection with a fluorescent biomarker called Meso-Tetra (4-Carboxyphenyl) Porphine, or TCPP.
Published results of the Patriquin, et al., clinical trial of a microscopy-based test demonstrate overall 81% accuracy and confirm that TCPP is an important biomarker for lung cancer detection. This study of New Mexico military veterans at high risk for lung cancer uses cytology to identify cells labeled by TCPP indicating cancer is present. The trial builds upon an earlier study at Los Alamos National Laboratory of 12 uranium miners that resulted in 100% sensitivity and 100% specificity.
bioAffinity Technologies' scientific team, led by Vivienne Rebel, MD, PhD, an award-winning cancer stem cell biologist, improves performance and commerciality of CyPath® Lung by designing a flow cytometry-based test that allows for rapid capture of data from millions of sputum cells to identify cancer-related cell populations that indicate malignancy.
bioAffinity Technologies and Precision Pathology Services, an established anatomical pathology laboratory serving hospitals and physicians for 18 years, begin commercialization of CyPath® Lung as a Laboratory Developed Test (LDT) accredited by the College of American Pathologists (CAP) and certified under the US Centers for Medicare and Medicaid Services (CMS) Clinical Laboratory Improvement Act (CLIA).
bioAffinity Technologies and Precision Pathology Services initiate CAP/CLIA validation of CyPath® Lung.
bioAffinity Technologies conducts successful Intial Public Offering, leading to acquistion of Precision Pathology Services in 2023.
The CyPath® Lung clinical trial results in 92% sensitivity and 87% specificity in high-risk patients with small pulmonary nodules, as published in Respiratory Research, a leading peer-reviewed journal. More than half of those in the cancer cohort had early Stage I or II lung cancer. Multiple types of lung cancer were detected including adenocarcinoma, squamous cell carcinoma and small cell lung cancer.
CyPath® Lung is awarded Medicare, commercial payer, and federal reimbursement, spurring greater physician adoption. Pulmonologists at South Texas VA Medical Center and Brooke Army Medical Center publish a study in a peer-reviewed journal evaluating the potential economic impact of adding CyPath® Lung to the standard of care, resulting in significant cost savings for patients and America's healthcare system.
Physicians offer compelling patient case studies including published reports of CyPath® Lung detecting curative Stage 1A lung cancer in patients where other diagnostic approaches proved wrong or were contraindicated.
Statement From Our President & CEO
— Maria Zannes, bioAffinity Technologies President & CEO
Our Company’s Why
President & CEO Maria Zannes discusses the origins of bioAffinity Technologies and why we are dedicated to the early diagnosis and treatment of cancer.