CerTest Biotec, BD Announce Addition of Saliva to the CE Marked VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for BD MAX™ Molecular Diagnostic System

Tuesday, April 27, 2021

CerTest Biotec, along with BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit for the BD MAX™ Molecular Diagnostic System can now be run on saliva specimens.

This allows BD MAX™ System users more flexibility with three alternatives for specimen collection: nasopharyngeal, oropharyngeal and saliva. This kit, CE marked to the IVD Directive (98/79/CE), detects all currently identified variants of SARS-CoV-2.

As the COVID-19 pandemic continues to impact Europe with additional lockdowns planned in some countries, the ability to test an ample portion of the population and identify infected people is critical to helping contain the spread and limit additional waves of the disease.  

"Together with BD, we can now offer patients a non-invasive way to be tested for COVID-19 and combine that ease and comfort with the sensitivity and specificity of the RT-PCR method," said Nelson Fernandes, managing director of CerTest BioTec.

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

"This new specimen type alternative for VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for the BD MAX™ System is complementing our versatile respiratory menu and is one step further in our goal to reach more patients with the right test and at the right time," said Nikos Pavlidis, vice president of Molecular Diagnostics at BD.

VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for the BD MAX™ Molecular Diagnostic System is sold through BD's distribution network. The test snaps into the test-specific position on the BD MAX™ ExK™ TNA Extraction Strip, supplied by BD.

To locate a 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 vary in different countries; please contact your local BD representative.

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 70,000 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 or connect with us on LinkedIn at www.linkedin.com/company/bd1/ and Twitter @BDandCo.

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.

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