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Политика за бисквитките

About bioAffinity
Technologies

The people behind the
science of better futures.

Executive Management

Board of Directors

OUR HISTORY

Rooted in Science, Driven by Purpose

Founded: March 2014

Initial Public Offering: September 2022

CEO: Maria Zannes

2014

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.

2015

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. 

2017-2018

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.

2019-2020

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).

2021

bioAffinity Technologies and Precision Pathology Services initiate CAP/CLIA validation of CyPath® Lung.

2022

bioAffinity Technologies conducts successful Intial Public Offering, leading to acquistion of Precision Pathology Services in 2023.

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.

2024

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.

2025

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

“CyPath® Lung, our non-invasive test to detect lung cancer at its early stages when treatment is most effective, will give more people more time by significantly lowering the death rate of this deadliest of cancers. The hard-working scientists and other professionals at bioAffinity are committed to bringing to market products that give people longer, healthier lives by the early detection of cancer and other lung diseases, and advancing therapeutic discoveries that treat cancer at the cellular level. Flow cytometry allows for analysis of whole cells and cell populations that make up the lung environment. Our research provides a better understanding of how disease changes the lung environment and how flow cytometry can be used as a diagnostic tool by analyzing sputum for the presence of lung cancer, as well as other diseases such as COPD and asthma.”

 — 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.