Biomerica Receives CE Mark for New High-Volume Production Version of COVID-19 IgG/IgM Rapid Test

Biomerica Inc. (Irvine, CA, USA) has received a CE mark and launched a new high-volume production version of its COVID-19 IgG/IgM Rapid Test in countries outside the US.

Biomerica has shipped and continues to supply the previously announced cassette version of its disposable finger prick test to its distribution partners who are supplying multiple customers that include NATO, and government agencies in Germany, Switzerland and the Netherlands among others. The new high-volume version of the test uses the same technology as the cassette version which has been well accepted in Europe and other countries in terms of performance.


The high-volume version of the disposable serology test allows Biomerica to ramp up production utilizing a proprietary card system that eliminates most plastic and expand its international distribution to better meet demand of its 10-minute test for coronavirus exposure. The environmentally friendly test is intended for larger customers doing high-volume screenings and can be performed anywhere by trained professionals, e.g. airports, schools, work, doctor’s office utilizing blood from a finger prick.

Biomerica has also expanded its provisional patent applications to include new technology that is being validated to simplify blood sample collection for its high throughput ELISA test. The company expects to launch its ELISA high-volume laboratory version serology test with high accuracy and low cross-reactivity in accordance with the newly released EUA guidance.

“The devastating effects on the lives of people affected by COVID-19 continue to be problematic,” said Zackary Irani, Chairman and Chief Executive Officer. “Our existing point of care test has been well accepted in international markets and we are now expanding sales distribution to other countries. Our launch of these COVID-19 serology tests is by no means a shift in the company’s stated strategy of growing both our colorectal disease detection product, finalizing clinical trials and gaining FDA approval for our HP Detect H. Pylori test and our InFoods IBS therapy product.”