IRVINE, Calif.—Biomerica Inc. has announced the signing of two separate definitive license agreements with the Icahn School of Medicine at Mount Sinai to license technologies for a laboratory version serological test for SARS-CoV-2 (COVID-19) infection. These technologies were developed at Mount Sinai. The test uses the ELISA microplate format that can run on existing open system equipment, which can be found in most hospitals and clinical laboratories in the U.S.
Biomerica has extensive serological test development, scale-up and manufacturing capabilities and expertise. Based on the data from Mt. Sinai, Biomerica intends to scale up commercial manufacturing of the licensed technology. The company has the equipment and capacity to manufacture over a million tests in the ELISA microplate format per month at its manufacturing facility in Irvine, California.
While Biomerica states there are unknowns about the transfer and scale-up process, if successful the company believes that it could have commercial sales within weeks. Biomerica plans to file for expedited clearance for this new test format with the U.S. Food and Drug Administration, under the Emergency Use Authorization process.
“If [a] person has already been infected with SARS-CoV-2, they develop antibodies through an immune response that should give them immunity,” stated Zackary Irani, chairman and chief executive officer of Biomerica. “The entire Biomerica team is working tirelessly to make our low-cost tests available to the hundreds of requests we have received.”
This ELISA microplate format is a serology test that detects antibodies in the blood of patients who have been infected with COVID-19. The antibodies show up in detectable quantities approximately 8 days after infection, and remain detectable for at least 3 months. People who have tested positive for the antibodies and are no longer infectious can possibly be cleared to return to work, as they have a lower likelihood of reinfection and/or spreading the virus.
Serology tests may turn out to be a powerful tool for identifying anyone who has been infected, whether they were symptomatic or not. Serological testing is important in identifying the total number of people who have been infected with COVID-19, and will allow for further studies that establish whether the immune response protects from future reinfection. This type of testing could also be particularly important for the immune surveillance of health care workers, first responders, government workers and others whose infection risks are heightened by working with COVID-19 infected individuals.