CerTest Biotec and BD Announce CE Mark for Combination COVID-19, Influenza, RSV Test on BD MAX™ Molecular Diagnostic System

CerTest Biotec along with BD announces that the VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit adapted for the BD MAX™ System has been CE marked* to the IVD Directive (98/79/EC).

This kit allows BD MAX™ System users to run a single module that tests concurrently for COVID-19 and Influenza (Flu) and Respiratory Syncytial Virus (RSV).

Nelson Fernandes, managing director of CerTest Biotec Said: "The new CerTest kit will provide rapid COVID-19 diagnostic capabilities that can be run individually or combined with detection of Flu A, Flu B and RSV A and B, As we enter flu season, the ability to test for both COVID-19 and Flu at the same time will speed diagnosis and, ultimately, treatment."

The BD MAX™ System, a molecular diagnostic platform, is widely used in hundreds of laboratories across Europe. Each unit can return results in two to three hours and is capable of analyzing hundreds of samples over a 24-hour period.

Nikos Pavlidis, vice president of Molecular Diagnostics and Women's Health for BD Said: "Together with CerTest, we can offer our customers in Europe a complete solution for COVID-19 diagnostics during the winter season, By leveraging our significant installed base and the versatility of the BD MAX System, this test will greatly enhance capacity for SARS-CoV-2 and Influenza testing, enabling clinicians to rapidly diagnose patients and help reduce the spread of COVID-19."

The CerTest tests snaps into the test-specific position on the BD MAX™ ExK™ TNA extraction strip, supplied by BD.

VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for the BD MAX™ System and the VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit for the BD MAX™ System are sold through BD's network and are not available for sale in the United States. To locate an authorized BD representative or request information, visit: www.bd.com or www.certest.es

* VIASURE Kits are not available for sale in the U.S. Product availability may differ in different countries, please contact your local BD representative.

SOURCE BD (Becton, Dickinson and Company)

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