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

ZARAGOZA, Spain and FRANKLIN LAKES, New Jersey, Oct. 21, 2020 /PRNewswire/ -- 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.

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.

About CerTest
CerTest Biotec is a European company established in 2002 for the development and manufacturing of in vitro diagnostic medical devices.

Today, CerTest is a global company structured around 5 business units offering one of the widest portfolios for human In Vitro Diagnostic. The company bases its future on a strong technical knowledge and expertise in the detection of human diseases.

CerTest last generation laboratories, state-of-the-art technical equipment and skilled professionals are the keys for providing reliable solutions for the medical diagnostic professional.

About BD
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.

*BD and BD MAX trademarks are property of BD (Becton, Dickinson and Company).

*VIASURE is a registered trademark of CerTest Biotec, S.L.

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