FAQ - December, 1st 2021
bioMérieux's role in the fight against COVID-19
Please note that this FAQ addresses the situation as of its date of issue. It is by nature, an evolving document.
bioMérieux has been a major global player in the field of diagnostics for infectious diseases for more than 55 years.
True to our public health mission we decided at the early onset of the epidemic to start working on the development of diagnostic tests for the detection of the SARS-CoV-2 virus responsible for the COVID-19 disease.
In this global health crisis of unprecedented proportions, bioMérieux's strategy to help governments and healthcare professionals fight the spread of the COVID-19 pandemic is based on the development of complementary molecular and immunoassay tests and our expertise in automated nucleic acid extraction. We are currently able to provide six complementary molecular biology tests and three serological tests. Our tests have the necessary high quality, validation and regulatory market approvals to ensure patient and lab professional's confidence. Last June, bioMérieux also launched EPISEQ® SARS-COV-2, a cloud-based software application for the epidemiological surveillance of SARS-CoV-2 variants.
Our teams in the field and in manufacturing sites worldwide continue to be fully committed to meet our customers’ needs across the world.
We are following the evolution of the pandemic and the scientific knowledge about the virus with the utmost attention and continuously work to anticipate developments in diagnostic tests that will meet future public health needs.
bioMérieux's strategy to fight COVID-19 illustrates our commitment to serve public health. It is based on the provision of molecular biology tests, our expertise in the field of automated nucleic acid extraction and in the field of immunoassays for the supply of serological tests.
- The monoplex tests ARGENE SARS-COV-2 and COVID-19 R-GENE® (simpler and faster) uses real-time PCR technology to specifically detect the coronavirus responsible for the COVID-19 pandemic. To develop these tests, bioMérieux worked with internal and external scientific experts to take into account state of the art knowledge in the test design. As a complement to nasopharyngeal swab specimens, these tests may be used on saliva.
- SARS-COV-2 RESPI R-GENE® allows the simultaneous (multiplex) detection and identification of SARS-CoV-2 , influenza viruses A and B, and two other respiratory pathogens (RSV and hMPV).
These tests are available in certain international markets. All tests in the ARGENE® range may be performed by any laboratory using PCR technology with a large number of validated nucleic acid extraction and amplification platforms. Results are delivered in 4 to 5 hours, and a large number of patient samples may be processed simultaneously. The entire ARGENE® range for the detection of SARS-CoV-2 is produced in France at the bioMérieux site in Verniolle (Ariège).
- BIOFIRE® Respiratory Panel 2.1 is an expanded version of the existing molecular biology syndromic panel that includes SARS-CoV-2 virus in addition to the 21 other common respiratory pathogens that the test is able to detect in about 45 minutes.
- BIOFIRE® Respiratory Panel 2.1 plus available in international markets, includes the 21 common respiratory pathogens plus detection of MERS-Coronavirus in addition to the SARS-CoV-2 virus.
Both panels are available on the BIOFIRE® FILMARRAY® 2.0 and BIOFIRE® FILMARRAY® TORCH platforms.
- The BIOFIRE® Respiratory 2.1-EZ (RP2.1-EZ) Panel identifies 15 viruses – including SARS-CoV-2 – and 4 bacteria responsible for common respiratory infections. It is only available in the USA for use outside the laboratory ("CLIA-Waived").
- During the COVID-19 pandemic, bioMérieux continues to produce its EMAG® and easyMAG® systems and associated reagents for the nucleic acid (NA) extraction prior to the amplification and detection of specific gene sequences. Reagents are produced in France, instruments in Italy.
Building on years of experience in the development of immunoassays, bioMérieux worked closely with several hospitals to develop and validate the performances of two serological tests.
- VIDAS® SARS-COV-2 IgM and SARS-COV-2 IgG are two individual tests which identify in less than 30 minutes the presence of specific antibodies in people who have been infected with SARS-CoV-2.
In this context, clinical and analytic specificity is particularly important to ensure that testing of uninfected individuals consistently shows a negative result.
- VIDAS® SARS-COV-2 IgG II, allows for semi-quantitative antibody detection in people who have been infected by SARS-CoV-2 or who have been vaccinated.
All VIDAS® SARS-COV-2 immunoassays demonstrated excellent clinical specificity performance. They are developed and manufactured in France.
|ARGENE SARS-COV-2 R-GENE®||YES||EUA*|
|SARS-COV-2 RESPI R-GENE®||YES|
|BIOFIRE® Respiratory Panel 2.1||De Novo**|
|BIOFIRE® Respiratory Panel 2.1 plus||YES|
|BIOFIRE® Respiratory 2.1-EZ||EUA*|
|VIDAS® SARS-COV-2 IgM and anti-SARS-COV-2 IgG||YES||EUA*|
|VIDAS® SARS-COV-2 IgII||YES|
* EUA: Emergency Use Authorization (FDA)
** De Novo: Regular FDA clearance pathway
GENETIC SEQUENCING-BASED SOFTWARE APPLICATION
In June 2021, bioMérieux launched EPISEQ® SARS-COV-2, a genomic sequencing-based software solution to support microbiology labs in identification and analysis of raw sequencing data related to SARS-CoV-2 variants. Automatically updated each week, the platform identifies variants (mutations) based on international nomenclatures (Pango and Nextstrain) including any new variants of concern such as Delta and Omicron, as defined by the World Health Organization and the US Centers for Disease Control and Prevention.
A number of SARS-CoV-2 variants are currently circulating worldwide and new variants with mutations are regularly identified. Some of these variants are under particular scrutiny because of their impact on the pandemic (increased infectiousness or severity of infection or possible vaccine ineffectiveness).
bioMérieux's research and development teams closely monitor the emergence of these variants of concern and systematically conduct in-depth internal analyses.
These analyses allow us to confirm that none of the variants of public health concern identified to date have an impact on the performance of our molecular tests, in particular the Alpha , Beta, Gamma, Delta and Omicron variants.
Regarding immunoassays, we are very vigilant in monitoring the scientific literature and in testing infected patients' samples to assess if the mutations specific to each variant are involved in reducing the ability of our serology tests to detect the body’s antibody response. To date, we have not observed any significant reduction in the performance of our serology tests due to emergence of variants of concern.