On August 4, 2020 bioAffinity Technologies, a privately held biotech company, reported a poster explaining the Company’s use of flow cytometry for diagnosis of lung disease, including cancer, at the International Society for Advancement of Cytometry CYTO 2020 (Press release, BioAffinity Technologies, AUG 4, 2020, View Source [SID1234562844]). The CYTO 2020 conference runs today and tomorrow in a virtual format due to COVID-19.
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"We are pleased to have the opportunity to share our cutting-edge use of flow cytometry for accurate, non-invasive lung cancer diagnosis. Our platform not only advances early lung cancer testing, but also can be developed to detect other diseases of the lung," bioAffinity President and Chief Executive Officer Maria Zannes said.
The Company’s first product, CyPath Lung, is a flow-cytometric test to aid in the diagnosis of lung cancer. Flow cytometry allows for quantitative analysis of cells and cell systems. In the CyPath Lung process, individual cells are suspended and then analyzed by flow cytometry one at a time through a focus of exciting light, which is scattered in patterns characteristic to the cells and their components. Cells are labeled with fluorescent markers so that light is first absorbed and then emitted at altered frequencies. A sensor in the flow cytometer detects the scattered or emitted light and measures the size and molecular characteristics of individual cells. This allows for cellular profiles of sputum samples that can used to distinguish cancerous from cancer-free lungs.
"Data acquisition and our automated analysis is very fast," Ms. Zannes said. "CyPath Lung can analyze an average sputum sample of about 21 million cells in less than 20 minutes."
CyPath Lung allows patients to 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 and surgery currently used to diagnose lung cancer. CyPath Lung is a well-balanced, highly accurate test.
CyPath Lung has been licensed by Precision Pathology Services, a CAP/CLIA laboratory in San Antonio, Texas. Precision Pathology Services anticipates certification and sale of CyPath Lung in 2020 as a Laboratory Developed Test (LDT). Following its certification as an LDT, physicians will order CyPath Lung 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.
Using CyPath Lung after a positive LDCT screen can improve the PPV by 5.6-fold compared to LDCT alone. Early diagnosis of lung cancer followed by treatment has been shown to increase the 10-year survival rate of the disease to 88% from the present 5-year survival rate of 21.7%.