Information on COVID-19

FAQ - May, 5th 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.

1. bioMérieux’s strategy in response to COVID-19 pandemic

2. What diagnostic solutions does bioMérieux provide for COVID-19?

3. Can bioMérieux's diagnostic solutions detect SARS-CoV-2 variants?

 


1. bioMérieux’s strategy in response to COVID-19 pandemic

bioMérieux has been a major global player in the field of diagnosis of 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 four complementary molecular biology tests and two serological tests. Our tests have the necessary high quality, validation and regulatory market approvals to ensure patient and lab professional's confidence.

Our teams in the field and in manufacturing sites worldwide continues 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.

2. What diagnostic solutions does bioMérieux provide for COVID-19?

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.

MOLECULAR BIOLOGY

  • The ARGENE SARS-COV-2 R-GENE® test uses real-time PCR technology to specifically detect the coronavirus responsible for the COVID-19 pandemic. To develop this test, bioMérieux worked with internal and external scientific experts to take into account state of the art knowledge in the test design. The French National Reference Center on Viral Respiratory Infections validated the test and demonstrated its excellence performance. As a complement to nasopharyngeal swab specimens, this singleplex test may be used on saliva and oropharyngeal (throat) swab specimens. (More info)
  • The SARS-COV-2 RESPI R-GENE® multiplex test relies on real-time PCR technology for the simultaneous detection of SARS-CoV-2, influenza viruses A and B, and RSV and hMPV viruses. (More info)

All tests in the ARGENE® range may be performed by any laboratory using PCR technology on commercially-available 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).

  • The BIOFIRE® COVID-19 test is fully automated. It provides results from a patient sample in 45 minutes. It is suitable for use in emergency situations for patients in critical health condition. The BIOFIRE® COVID-19 test, developed with funding from the U.S. Department of Defense (DoD), is produced in Salt Lake City, Utah. (More info)
  • The 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. (More info)
    • The BIOFIRE® Respiratory Panel 2.1 plus includes the detection of MERS-Coronavirus in addition to the SARS-CoV-2 virus.
    • Both panels are available on the FILMARRAY® 2.0 and FILMARRAY® TORCH platforms.
  • The BIOFIRE® Respiratory 2.1-EZ (RP2.1-EZ) Panel identifies 15 virus – 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.

IMMUNOASSAYS

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 identify in less than 30 minutes 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 shows a negative result.
  • Both VIDAS® SARS-COV-2 IgM and SARS-COV-2 IgG demonstrated excellent clinical specificity data. They are developed and manufactured in France. (More info)

 

CE Marked

FDA authorization

ARGENE SARS-COV-2 R-GENE®

YES

EUA

SARS-COV-2 RESPI R-GENE®

YES

 

BIOFIRE® COVID-19 test

 

EUA

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

 

3. Can bioMérieux's diagnostic solutions detect SARS-CoV-2 variants?

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, vaccine escape).
 
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 20I/501Y.V1 (United Kingdom), 20H/501Y.V2 (South Africa), 20J/501Y.V3 (Brazil) and 20A/484Q (India) 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 antibodies recognition and/or neutralizing epitopes.