MARCY L’ÉTOILE, France--(BUSINESS WIRE)--Regulatory News:
bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced the CE marking of VIDAS® anti-SARS-CoV-2 serology tests to detect antibodies in people who have been exposed to SARS-CoV-2 which causes the COVID-19 disease.
VIDAS® anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG are used to measure the presence of antibodies in people who have been infected with SARS-CoV-2. In this context, clinical specificity is particularly important to ensure that testing of uninfected individuals consistently delivers a negative result. Both VIDAS® anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG provide results in less than 30 minutes and demonstrate excellent performance on a large number of clinical specimens, with 99.4% and 99.9% specificity, respectively.
“We are pleased to provide laboratories with high quality serology tests for the confirmation of SARS-COV-2 infections. Specialized in the development of diagnostic solutions to fight infectious diseases for over 55 years, bioMérieux now offers a wide range of tests that meet the needs of health professionals in a variety of clinical situations related to patients’ conditions in the context of the COVID-19 pandemic,” said François Lacoste, Executive VP R&D at bioMérieux.
From now on, the tests are available in Europe and in countries that recognize CE marking. Hospital and private laboratories will be able to run the tests on bioMérieux’s VIDAS® systems (MINI VIDAS®, VIDAS® and VIDAS® 3) which are widely used with more than 30 000 systems installed around the world.
bioMérieux is planning to submit a request for Emergency Use Authorization (EUA) to the US Food and Drug Administration shortly.
A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux is present in 44 countries and serves more than 160 countries with the support of a large network of distributors. In 2019, revenues reached €2.7 billion, with over 90% of international sales.
bioMérieux provides diagnostic solutions (systems, reagents, software and services) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.
bioMérieux is listed on the Euronext Paris stock market.
Symbol: BIM – ISIN Code: FR0013280286
Reuters: BIOX.PA/Bloomberg: BIM.FP
Corporate website: www.biomerieux.com.