Updated March 24, 2020
Below, you will find the most up to date information and commonly asked questions from our customers. Should you need more information, please contact your local sales representatives or send us an email to firstname.lastname@example.org. To view our latest press release, please click here.
Frequently Asked Questions in the U.S.
WHEN DOES BIOMÉRIEUX EXPECT SARS-CoV-2 TESTS TO BE AVAILABLE IN THE U.S.?
A BIOFIRE® COVID-19 test has received Emergency Use Authorization by the FDA on March 24, 2020. The test detects SARS-CoV -2 in approximately 45 minutes from a Nasopharyngeal swab in transport media. This test runs on the fully automated FILMARRAY® 2.0 and FILMARRAY® TORCH platforms. We expect to provide kits to the US Department of Defense next week and roll out to the US clinical Market in April 2020.
For the SARS CoV-2 RGENE We are consistently pursuing any possible areas where we can save time in the process, currently, we are looking at an Emergency Use Authorization (EUA) submission.
BIOFIRE® RESPIRATORY 2.1 PANEL (including SARS-CoV2 detection). We expect this newly expanded syndromic panel to be available in July 2020 under FDA EUA, and we also plan to seek for FDA 510K clearance.
WHAT EDUCATION IS BIOMÉRIEUX PROVIDING TO STAFF REGARDING COVID-19?
- bioMérieux has updated the bioMérieux Connection blog with a dedicated article titled, Responding to COVID-19 in a Climate of Uncertainty. It leverages information made available from CDC, WHO and other available resources about what is known about COVID-19.
- A dedicated global internal site was created for easy access to the most updated guidelines such as: working from home, travel policy, safety recommendations, precautions about how to interact with HCPs and more. This site provides access to all internal communications through all subsidiaries in several languages.
HOW IS BIOMÉRIEUX MANAGING SERVICE CONTINUITY?
bioMérieux is fully committed to delivering the quality service and support our customers need. We have taken precautionary measures to reduce our employees' risk of exposure to COVID-19 by allowing non-essential employees to work remotely. Our Field Service Team (including Engineer and Application team members) will be available during normal business hours, and our customer hotline is available 24 hours a day and 7 days a week.
Furthermore, we remind our valued customers to utilize remote access technology for rapid response, such as VILINK® (remote instrument support).
HOW IS BIOMÉRIEUX MANAGING MANUFACTURING OF ITS EXISTING SOLUTIONS?
bioMérieux is closely monitoring supply/demand to ensure every effort is made to secure the increased demand for NUCLISENS® and BIOFIRE® reagents and instruments.
In support of our public health mission during this unprecedented time, our team is actively working to increase manufacturing production to meet customer needs while keeping our quality standards to the highest level and compliant with our internal safety guidelines.
HOW IS BIOMÉRIEUX MANAGING MANUFACTURING OF NEW TESTS AND INCREASED REQUESTS FOR INSTRUMENTATION?
bioMérieux is proactively planning to increase manufacturing capabilities to ensure our essential products are available to meet the anticipated increase in demand for the new ARGENE® and BIOFIRE® tests. Currently, none of our sites have been affected or compromised, and we will remain in full operation while following our corporate guidelines for employee safety.