bioMérieux has received Emergency Use Authorization by the U.S. Food and Drug Administration of its VIDAS® SARS-COV-2 IgM and VIDAS® SARS-COV-2 IgG serology tests.
DURHAM, N.C. – August 7, 2020 –– bioMérieux, a world leader in the field of in vitro diagnostics, is announcing today that it has received Emergency Use Authorization by the U.S. Food and Drug Administration of its VIDAS® SARS-COV-2 IgM and VIDAS® SARS-COV-2 IgG serology tests. These tests are intended for use as an aid in identifying individuals with an adaptive immune response to SARS‑CoV‑2, indicating recent or prior infection.
Building on decades of experience in developing immunoassays, bioMérieux worked closely with several academic medical centers to develop and validate the performance of the two tests. In less than 30 minutes, the VIDAS® SARS-COV-2 IgM and VIDAS® SARS-COV-2 IgG tests can detect the presence of antibodies to the SARS-CoV-2 spike glycoprotein in people who have been infected with SARS-CoV-2 virus. In this context of the COVID-19 pandemic, clinical specificity is particularly important to ensure that testing of uninfected individuals consistently shows a negative result. Both tests have demonstrated excellent clinical performance, with 100% sensitivity, and 99.4% or greater specificity.1
“Slowing the spread of COVID-19 has been challenging for everyone and the pandemic has further proved just how critical the role of diagnostics is in the fight against infectious disease,” said Brian Armstrong Head of North America Clinical Operations of bioMérieux. “We are proud to launch the VIDAS® SARS-CoV-2 antibody tests, further expanding our COVID-19 comprehensive solutions to support faster diagnosis and treatment decisions and prevention of transmission.”
The bioMérieux VIDAS® SARS-COV-2 tests are commercially available and laboratories can run them on all VIDAS® systems, which includes the MINI VIDAS®, VIDAS®, and VIDAS® 3.
bioMérieux already provides several solutions for the molecular detection of SARS-CoV-2:
A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux is present in more than 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
U.S. website: www.biomerieux-usa.com
Investor Relations
bioMérieux
Sylvain Morgeau
Tel.: +33 4 78 87 51 36
investor.relations@biomerieux.com
Media Relations
SEEZ
Liza Deckelbaum
Tel.: (919) 645-0782
lizad@thestoneagency.com
1≥15 days post symptoms onset
- BIOFIRE® RESPIRATORY PANEL 2.1, BIOFIRE® COVID-19, SARS-COV-2 R-GENE®, and VIDAS® SARS-COV-2 tests have not been FDA cleared or approved;
- BIOFIRE® RESPIRATORY PANEL 2.1, BIOFIRE® COVID-19, SARS-COV-2 R-GENE®, and VIDAS® SARS-COV-2 tests have been authorized by FDA under an EUA for use by authorized laboratories;
- BIOFIRE® RESPIRATORY PANEL 2.1, BIOFIRE® COVID-19, SARS-COV-2 R-GENE® tests have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens;
- VIDAS® SARS-COV-2 tests have been authorized only for the detection of IgG and IgM antibodies against SARS-CoV-2, not for any other viruses or pathogens;
- BIOFIRE® RESPIRATORY PANEL 2.1, BIOFIRE® COVID-19, SARS-COV-2 R-GENE®, and VIDAS® SARS-COV-2 tests have only been authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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