Biomerica Files for EUA for its COVID-19 Laboratory Antibody Test

Biomerica submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for an ELISA lab-based serology blood test for the detection of antibodies that identify if a person has been infected with the novel coronavirus (COVID-19). This is the third COVID-19 antibody test introduced by the Company. The Company intends to obtain a CE mark to market and sell this ELISA laboratory test outside the US.

Biomerica performed testing both internally and at two external labs located in California. The data from this testing that was submitted to the FDA under the EUA application showed 100 percent specificity and zero percent cross reactivity with many common disease states. This test, which uses the ELISA microplate format, runs on existing open system equipment found in most hospitals and clinical laboratories in the US and outside the US and uses a modified, trimeric spike protein from the SARS-CoV-2 virus. This spike protein is known to be the target of neutralizing antibodies, which can help prevent the virus from entering the cells. Persons who are no longer infectious and have tested positive for the antibodies, can possibly be cleared to return to work as they may have a lower likelihood of reinfection and/or spreading the virus. Antibody tests will also help in better understanding the virus including how long antibodies stay in the body and if they help in immunity as well as how many people have been infected in the population as a whole. Further, this type of testing could be particularly important for the immune surveillance of health care workers, first responders, government workers, and others whose infection risks could be heightened by working with COVID-19 infected individuals.

This ELISA laboratory test was developed by Biomerica and will be manufactured exclusively at Biomerica’s manufacturing facility located in Irvine, California, using existing high-throughput, automated equipment. Biomerica has extensive experience manufacturing similar serology ELISA tests for other diseases.

"We are working to provide significant, high specificity and meaningful diagnostic solutions for the novel Coronavirus," said Zack Irani-Cohen, CEO and Chairmen of Biomerica. "Our ELISA test will be unique in the market place by simplifying the blood sample collection process in a proprietary way. We have been working with the FDA, who has been very responsive, and we’re looking forward to a quick review for this submission. I’m very proud of our team members who are working around the clock to develop, validate and attain regulatory clearance on these covid-19 diagnostic solutions that benefit patients, healthcare workers and society”.

Serology tests look for the presence of antibodies, which are specific proteins made in response to infections. The antibodies detected by serology tests indicate that a person has had an immune response to the novel Corona Virus (SARS CoV-2), whether symptoms developed from infection or the infection was asymptomatic. Antibody test results are important in detecting infections with few or no symptoms.