Information on business continuity
FAQ - July 15, 2020
Please note that this FAQ addresses the situation as of its date of issue. It is by nature, an evolving document.
bioMérieux’s strategy in response to COVID-19 pandemic
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.
bioMérieux's strategy is primarily based on the launch of three complementary molecular biology tests as well as its continuing expertise in automated nucleic acid extraction and on itsexpertise in immunoassays with the validation of serology tests preceding imminent launch.
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 are fully committed to meet as much as possible, our customers’ and more generally public health needs across the world.
Today's global health crisis highlights the crucial role diagnostics play in the healthcare pathway. In countries where the epidemic is present, lab tests are essential for appropriate patient care. They also bring health authorities essential information on the scale and magnitude of the epidemic to adapt their strategies. To date, molecular biology (RT-PCR tests) is the recommended technology to provide fast and accurate diagnosis.
In the short to medium term, serology tests will play a key role in monitoring the immune status of general or specific populations.
bioMérieux's strategy to combat COVID-19 illustrates our commitment to serve public health. It is based on the development of complementary molecular and immunoassay tests and our expertise in automated nucleic acid extraction.
The ARGENE SARS-CoV-2 R-GENE® test had been finalized. This test relies on the real-time PCR* technology to specifically detect the coronavirus responsible for the COVID-19 pandemic.
It can be used with most commercially available nucleic acid extraction and amplification PCR-platforms.
The SARS-CoV-2 R-GENE® test allows many patients to be tested simultaneously. The result is provided in 4 to 5 hours.
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. Then, the French National Reference Center on Viral Respiratory Infections validated the test and demonstrated its excellence performance. The test, developed by our teams in Verniolle and Grenoble sites, is produced in Verniolle (France).
The second test developed by bioMérieux is the BIOFIRE® COVID-19 test. It is a fully automated test that 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 and has received an EUA from the FDA.
The third test developed by bioMérieux is an expanded version of its molecular biology syndromic panel, the BIOFIRE® FILMARRAY® Respiratory Panel 2.1 (RP2.1).
It includes SARS-CoV-2 virus in addition to the 21 other common respiratory pathogens and will deliver results in approximately 45 minutes
the BIOFIRE® Respiratory Panel 2.1 plus includes the detection of MERS-Coronavirus in addition to the SARS-CoV-2 virus.
Both panels will be available on the FILMARRAY® 2.0 and FILMARRAY® TORCH platforms.
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. These systems are in high demand as a means of preparing nucleic acids from clinical specimens for many SARS-CoV-2 RT-PCR tests available on the market. Reagents are produced in France, instruments in Italy.
- The fourth tests are serology assays. Building on years of experience in developing immunoassays, bioMérieux worked closely with several hospitals to develop and validate the performances of two tests. VIDAS® anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG
- They will 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® anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG demonstrated excellent clinical specificity data.
- They are developed and manufactured in France.
*Polymerase Chain Reaction
bioMérieux has developed two molecular diagnostic tests for COVID-19 in less than 2 months and a third complementary test to the first two is now available. Two serological tests have been validated and are available.
The ARGENE® SARS-CoV-2 R-GENE® test is validated in France since March 11 and is CE marked since April 10, 2020. It is cleared by the FDA for Emergency Use Authorization in the United States since May 6.
The BIOFIRE® COVID-19 test has been developed with funding from the U.S. Department of Defense (DoD). It has received Emergency Use Authorization by the U.S. FDA on March 23, 2020.
The new BIOFIRE® Respiratory Panel 2.1 (RP2.1), that integrates SARS-CoV-2 virus received Emergency Use Authorization by the U.S. FDA in May 4. The BIOFIRE® Respiratory Panel 2.1 plus includes the detection of MERS-Coronavirus in addition to the SARS-CoV-2 virus is CE marked since July 15.
VIDAS® anti-SARS-CoV-2 serology tests are CE marked since May 21 and bioMérieux will file a request for Emergency Use Authorization (EUA) to the US Food and Drug Administration.
As all industries, we are closely monitoring the challenging conditions all manufacturers and suppliers face, such as tension on supplies, absenteeism of employees, transportation challenges, etc.
Our teams are strongly mobilized in R&D, purchasing, manufacturing sites, online or on the field customer service and support, and in logistics. They demonstrate an unfailing commitment in working conditions that are of unprecedented complexity.
In general, the raw materials used in bioMérieux products are internally supplied or produced by a variety of life science companies. In particular, the producers of raw materials used in molecular biology are facing an exploding demand. We rely on the long-term partnership relationships we have developed with our raw material suppliers.
The international freight and air transport sectors are severely affected by the current situation and bioMérieux is working with service providers on an ongoing basis to secure deliveries. Connections between bioMérieux's international distribution centers and most countries are up and running and deliveries are being made. The situation can nevertheless be subjected to daily changes.
Our employees’ safety is our top priority. Our subsidiaries are following advice and regulations from local government and health agencies and making the appropriate adjustments to our operations. Several measures have already been taken to protect our employees all over the world, including work-from-home capabilities and limiting onsite presence to only employees essential to the sustainability of our operations. Other safety measures include, but are not limited to adhering to strict social distancing, mask usage and individual protection kits (masks, gloves, hydroalcoholic gel…).
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