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Coronavirus Antibody Test From Biomerica Gets CE Mark

NEW YORK – Biomerica said on Thursday it received a CE mark for its COVID-19 IgG/IgM Rapid Test for detecting antibodies to the SARS-CoV-2 coronavirus.

The Irvine, California-based firm has launched the test, which provides results in 10 minutes with a finger prick of blood, in countries outside the US. Biomerica said the high-volume version of the disposable serology test allows it to increase production using a proprietary card system that eliminates most plastic. The test is intended for large customers performing high-volume screenings.

In early April, the company announced it had licensed technologies from Mount Sinai's Icahn School of Medicine in New York related to a lab-based serological test for SARS-CoV-2.