Irvine-based Biomerica Inc. has submitted its ELISA lab-based serology blood test to the Food and Drug Administration for Emergency Use Authorization (EUA), making it the third type of coronavirus diagnostic for the company.
The serology test submitted for EUA has shown “100% specificity and zero percent cross-reactivity with many common disease states,” the company said in a statement. A common issue for coronavirus antibody tests has been false positives for other cross-reactive illnesses.
“Persons who are no longer infectious and have tested positive for the antibodies can possibly be cleared to return to work as they have a lower likelihood of reinfection and/or spreading the virus,” Biomerica said.
Biomerica’s test uses an ELISA, short for enzyme-linked immunosorbent assay, microplate format that can run on existing open systems available in most hospitals and clinical laboratories. ELISA is a type of lab test that detects and measures antibodies in the blood.
The company said the ELISA tests will be manufactured exclusively at its Irvine facility, which runs about 23,000 square feet.
The company in April said its production capacity at its California manufacturing facility will be over 3.5 million antibody tests per month.
Its shares have tripled this year to about $7.50 and an $85 million market cap as investors have bet the company can provide coronavirus tests.
The company has two other finger-prick antibody tests for use outside of the U.S. Those two tests are disposable, single-use devices available for less than $10 per test and require only a drop of blood. The 10-minute test determines if a person has the antibodies to the coronavirus, which means they have already been exposed to it.
Biomerica also manufactures an array of specialty tests for use at clinics and homes, including pregnancy, drug abuse and prostate or breast cancer. Its home test for colon cancer is one of its more significant products and is sold at pharmacy chains like CVS and Walgreens.
