Reveles leads CyPath® Lung, a non-invasive and highly accurate test for lung cancer, as it enters the market
OCTOBER 14, 2021
(SAN ANTONIO, TX)
bioAffinity Technologies today announced that Xavier T. Reveles, MS, CG, has been promoted to Vice President of Operations. Reveles will be responsible for overseeing the commercialization of the Company’s diagnostic products, including CyPath® Lung, a highly accurate, non-invasive test to diagnose early-stage lung cancer.
“Xavier has applied his more than 25 years of experience as a clinical geneticist skilled in the creation and management of clinical laboratories, coding and reimbursement valuations to the successful commercialization of CyPath® Lung,” bioAffinity President and CEO Maria Zannes said. “As we enter the market with our non-invasive cancer diagnostic, his skill, dedication and commitment to success will make bioAffinity a market leader in cancer diagnostics.”
bioAffinity announced in September that Precision Pathology Services, a CAP/CLIA-certified anatomic and clinical pathology laboratory, fully validated the clinical performance of CyPath® Lung, a non-invasive flow cytometric test for early-stage lung cancer. Precision Pathology licensed bioAffinity’s intellectual property for development of CyPath® Lung as a laboratory developed test (LDT).
Validation of CyPath® Lung was conducted in accordance with College of American Pathologists (CAP) guidelines and Clinical Laboratory Improvement Amendments (CLIA) regulations. The CAP/CLIA validation establishes and validates the performance of CyPath® Lung, including accuracy, precision, reproducibility and analytical specificity, that are necessary for commercialization. Precision Pathology has added CyPath® Lung to its menu of tests, and soon physicians will be able to order the test for their patients at high risk for lung cancer who receive a positive screening result or are otherwise suspected of having the disease.
CyPath® Lung is a flow cytometric test to aid in the diagnosis of lung cancer. Patients collect sputum samples non-invasively at home, a particular benefit during the COVID-19 pandemic. The sample is shipped overnight to the laboratory for processing. Sample data is acquired by flow cytometry, a technique that can count, sort and profile individual cells with remarkable speed. Using an automated analysis with pre-set parameters, CyPath® Lung profiles the lung environment, including the presence of cancer-associated cells. Data acquisition and physician reports can be generated in minutes.
bioAffinity Technologies recently completed a test validation trial of CyPath® Lung evaluating sputum from people at high risk for lung cancer, including patients with the disease and others who were cancer-free. The trial resulted in 92% sensitivity and 87% specificity in high-risk patients who had nodules smaller than 20 mm.
Reveles is board certified by the American Society of Clinical Pathology as a clinical specialist in cytogenetics. He has been bioAffinity Director of Operations since 2017. Prior to joining bioAffinity, Mr. Reveles was Laboratory Director for Oncopath Laboratory – START Cancer Center in San Antonio, Texas. During his tenure at Oncopath, he commercialized two LDTs including bringing to market a proprietary cancer specific oligo array he designed for the deletions and amplifications of specific oncogenes.
As the Director of the Cytogenetics Laboratory at UT Health San Antonio, Mr. Reveles’ research included molecular evaluation of disease progression in prostate, breast and ovarian cancer, schizophrenia, diabetes and other constitutional genetic syndromes. He was a lecturer and instructor for the UT Health Graduate, Medical, and Allied Health Schools. After leaving academia, Mr. Reveles was a genomic specialist for CombiMatrix Diagnostics where he validated multiple cancer arrays for commercialization as LDTs. Mr. Reveles is (co)author of 30 publications and three abstracts in peer-reviewed journals.
About bioAffinity Technologies
bioAffinity Technologies, Inc. (www.bioaffinitytech.com) is a privately held development-stage 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 is conducted in bioAffinity Technologies’ laboratories and at the University of Texas Health Science Center at San Antonio through a collaborative research agreement. The Company’s platform technology will be developed to diagnose, monitor, and treat many cancers. CyPath® Lung, bioAffinity’s initial product, is designed to be the first successful non-invasive, early-stage lung cancer diagnostic on the market.