CerTest Biotec and BD Announces the VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit Adapted for the BD MAX™

CerTest | October 21, 2020

CerTest Biotec, along with BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced 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). "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," said Nelson Fernandes, managing director of CerTest Biotec. "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. "Together with CerTest, we can offer our customers in Europe a complete solution for COVID-19 diagnostics during the winter season," said Nikos Pavlidis, vice president of Molecular Diagnostics and Women's Health for BD. "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.

Spotlight

On March 2, 2015, the National Health Council (NHC) and Genetic Alliance hosted an invitation-only Dialogue Event at the offi ces of the Food and Drug Administration (FDA) in Silver Spring, Maryland, including thought leaders involved in patient engagement policy, research, and implementation. Thirty-two participants representing the FDA, patient organizations, academia, and industry gathered to discuss key issues surrounding patient engagement in product research, development, and approval. By providing a forum for these thought leaders to share their perspectives, experiences, and expertise, the hosts hoped to establish a common vision to help drive meaningful integration of the patient voice in the product development and approval processes.

Spotlight

On March 2, 2015, the National Health Council (NHC) and Genetic Alliance hosted an invitation-only Dialogue Event at the offi ces of the Food and Drug Administration (FDA) in Silver Spring, Maryland, including thought leaders involved in patient engagement policy, research, and implementation. Thirty-two participants representing the FDA, patient organizations, academia, and industry gathered to discuss key issues surrounding patient engagement in product research, development, and approval. By providing a forum for these thought leaders to share their perspectives, experiences, and expertise, the hosts hoped to establish a common vision to help drive meaningful integration of the patient voice in the product development and approval processes.

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