bioAffinity Technologies Bolsters New Product Development Efforts

bioAffinity Technologies Inc. has named David Elzi, Ph.D., as vice president of Product Development to accelerate new diagnostics advancements based on the proprietary technology platform behind CyPath Lung, the company’s early-stage lung cancer detection test.
 
“As commercialization of CyPath Lung continues to meet or exceed our projections, new products that will improve patients’ lives are an essential part of our growth strategy, which is focused on expanding our portfolio of solutions for detecting serious lung health issues at an early stage when treatment can positively impact prognosis,” bioAffinity Technologies President/CEO Maria Zannes said. “Dr. Elzi has led our research team for eight years, helping to bring CyPath Lung to commercialization and now advancing two promising diagnostic products in the development phase.”
 
Both tests under development will use the company’s flow cytometry and artificial intelligence platform to analyze patient lung samples. One test in development analyzes bronchoalveolar lavage (BAL) fluid to identify cancer-predictive cell populations and is intended for use as a companion to bronchoscopy, a more invasive procedure used with patients who have a higher likelihood of lung cancer.
 
The second test under development analyzes sputum to improve chronic obstructive pulmonary disease (COPD) detection. COPD is an inflammatory lung disease that causes breathing-related problems and irreversible airflow obstruction for an estimated 16 million Americans, according to the Centers for Disease Control.
 
The research on both BAL and sputum samples for lung cancer and COPD is part of a collaboration between bioAffinity Technologies and the Fort Sam Houston Brooke Army Medical Center (BAMC), the largest military health organization within the U.S. Department of Defense (DOD). BAMC is currently enrolling DOD beneficiaries at high risk for developing lung cancer in a prospective observational study to address whether study subjects may have an alternative to annual low dose computed tomography (LDCT) screening and whether CyPath Lung can help predict cancerous lung nodules before more invasive procedures such as biopsy. Michael J. Morris, M.D., BAMC pulmonology physician and assistant dean of Research at San Antonio Uniformed Services Health Education Consortium (SAUSHEC), is the study’s principal investigator.
 
Dr. Elzi earned his Ph.D. in molecular and cellular biology from the University of Washington, in conjunction with the Fred Hutchinson Cancer Research Center. He subsequently performed post-doctoral research at the Bonfils Blood Center and University of Colorado Department of Surgery, where he studied the molecular mechanisms of transfusion-related lung injury. Before joining bioAffinity Technologies in 2016, he was a research scientist at the Greehey Children’s Cancer Research Institute, The University of Texas Health Science Center at San Antonio, where his research included applying proteomic techniques to study cellular senescence in primary and cancer cells.
 
CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin, meso-tetra (4-carboxyphenyl) porphyrin (TCPP), that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival.  
 
bioAffinity Technologies Inc. aims to address the need for noninvasive diagnosis of early-stage cancer and diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath Lung, is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies.