SEPTEMBER 29, 2020
(San Antonio, TX)
FAQ: Answers to Questions about Cypath® Lung
bioAffinity Technologies, a privately-held biotech company, today announced Martin Tammemägi, PhD, Professor Emeritus of Health Sciences at Brock University, will serve as Chairman of the bioAffinity Scientific and Medical Advisory (SMA) Board.
“Dr. Tammemägi is exceptionally well respected and a leader in cancer epidemiology, lung cancer screening and cancer risk prediction modeling,” bioAffinity President and Chief Executive Officer Maria Zannes said. “We are extremely pleased that he will lead our Scientific and Medical Advisory Board that includes dedicated physicians and scientists at the forefront of the fight against lung cancer.”
Dr. Tammemägi was a co-investigator and remains active in the U.S. Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO), the U.S. National Lung Screening Trial (NLST) and the Pan-Canadian Early Detection of Lung Cancer Study. He is an active associate member of the U.S. NIH NCI Cancer Intervention and Surveillance Modeling Network (CISNET) lung group and is the Provincial Scientific Lead for Ontario Health – Cancer Care Ontario’s Lung Cancer Screening Pilot for People at High Risk.
The SMA Board provides independent expert advice and counsel on bioAffinity’s research and development of cancer diagnostics, including CyPath® Lung, a non-invasive test for the early detection of lung cancer.
“The members of our Advisory Board are recognized leaders in the lung cancer field, especially as it relates to screening and early diagnosis when treatment options offer the best potential outcome,” said Vivienne Rebel, MD, PhD, bioAffinity’s Chief Science and Medical Officer and Executive Vice President. “Their groundbreaking work complements our mission to provide innovative products that have the potential to save thousands of lives every year.”
As SMA Board Chairman, Dr. Tammemägi replaces M. Patricia Rivera, MD, Professor of Pulmonary and Critical Care Medicine at the University of North Carolina at Chapel Hill, who was elected Secretary Treasurer of the American Thoracic Society (ATS), one of the country’s oldest and most prestigious healthcare organizations in the field of respiratory diseases. As an officer of ATS, Dr. Rivera must step down from industry advisory positions.
“We have greatly benefited from Dr. Rivera’s guidance,” Ms. Zannes said. “We thank her for her service on our advisory board and are very pleased that ATS will now have the benefit of her leadership and remarkable intellect.” ATS is an international society that includes more than 16,000 physicians, research scientists, nurses and other allied healthcare professionals dedicated to improving health worldwide by advancing research, clinical care and public health in respiratory disease, critical illness and sleep disorders.
Dr. Tammemägi will chair the bioAffinity Technologies SMA Board that includes:
- Neil Alexis, PhD, Principal Investigator at the University of North Carolina School of Medicine Center for Environmental Medicine, Asthma and Lung Biology. Alexis focuses on the use of sputum as a primary sampling tool for measuring cellular, biochemical and genetic outcomes in the human airway. Dr. Alexis is a leading expert in the use of flow cytometry in the analysis of sputum.
- Pierre Massion, MD, Professor of Medicine, Ingram Professor of Cancer Research and the Cornelius Vanderbilt Chair in Medicine at Vanderbilt University. Massion’s research emphasis is on lung tumorigenesis and genomic and proteomic approaches to identify molecular markers of lung neoplasia and to test those in multidisciplinary early detection strategies. He also is Co-Leader of Vanderbilt’s Cancer Health Outcomes and Control Research Program, and the Director of Cancer Early Detection and Prevention Initiative.
- Catherine Sears, MD, Assistant Professor of Medicine at Indiana University School of Medicine. Dr. Sears is a physician scientist whose laboratory focuses on the impact of DNA damage and repair on the development of smoking-related lung cancers and on treatment response. She co-chairs the pulmonary oncology and lung cancer screening programs at the Indianapolis VA Medical Center, and her clinical and research interests focus on improving lung cancer screening and early lung cancer detection and treatment.
- Gerard Silvestri, MD, MS, FCCP, Professor of Medicine and Lung Cancer Pulmonologist at the Medical University of South Carolina. Silvestri specializes in the evaluation, management and improvement of outcomes in lung cancer patients. He has experience in evaluating new technologies for the diagnosis and staging of lung cancer. His research includes screening for lung cancer, how patients should be diagnosed and staged with the disease, and how to evaluate new technologies needed to diagnose and treat these patients.
About CyPath® Lung
CyPath® Lung is a flow-cytometric test to aid in the diagnosis of lung cancer. Patients collect sputum samples non-invasively at home and ship them overnight to the laboratory for processing. Sample data is acquired by flow cytometry. Using automated analysis of pre-set parameters, CyPath® Lung profiles the lung environment including the presence of cancer cells. Data acquisition and physician reports can be generated in minutes.
A test validation trial comparing people at high risk for lung cancer to patients with the disease resulted in CyPath® Lung specificity of 88% and sensitivity of 82%, similar to far more invasive procedures currently used to diagnose lung cancer. CyPath® Lung performed even better, with 92% sensitivity and 87% specificity, in the group of cancer and cancer-free high-risk participants who had no nodules or small nodules less than 2 cm in diameter.
CyPath® Lung has been licensed by Precision Pathology Services, which is developing CyPath® Lung as a Laboratory Developed Test (LDT) in accordance with the College of American Pathologists (CAP) and the Clinical Laboratory Improvement Amendment (CLIA) guidelines and regulations. Precision Pathology Services is an accredited CAP/CLIA laboratory in San Antonio, Texas. Following the completion of the development of CyPath® Lung as an LDT, physicians may order the test for their patients who are smokers and former smokers at high risk for lung cancer and who receive a positive screening result or otherwise are suspected of having the disease.
People who have smoked the equivalent of one pack of cigarettes a day for 30 years or more, have not quit smoking in the past 15 years and are 55-80 years of age are recommended for annual screening by low dose computed tomography (LDCT). Screening by LDCT has been proven to detect lung cancer at earlier stages when it can be successfully treated, but screening has a low Positive Predictive Value (PPV) that can lead to unnecessary and risky procedures.
About bioAffinity Technologies, Inc.
bioAffinity Technologies, Inc. (www.bioaffinitytech.com) is a privately held company addressing the significant unmet need for non-invasive, early-stage cancer diagnosis and treatment. The Company develops proprietary in-vitro diagnostic tests and targeted cancer therapeutics using breakthrough technology that preferentially targets cancer cells. Research and optimization of its platform technology are conducted in bioAffinity Technologies’ laboratories at the University of Texas San Antonio (UTSA). The Company’s platform technology is being developed to diagnose, monitor and treat many cancers.