BD, CerTest Biotec Announce Commercial Launch of Monkeypox Test

Research Use Only (RUO) assay now available for BD MAX™ System users

FRANKLIN LAKES, N.J., July 27, 2022 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and CerTest Biotec today announced their newly developed molecular polymerase chain reaction (PCR) test for the monkeypox virus is now commercially available outside of the United States for use in research applications by laboratories.

The assay leveraged the BD MAX™ System open system reagent suite to develop the CerTest VIASURE Monkeypox molecular test on the BD MAX™ System.

"One of the key advantages of the BD MAX™ System is its open-architecture system that enables rapid response to emerging health threats," said Nikos Pavlidis, vice president of Molecular Diagnostics at BD. "Just as we did at the beginning of the COVID-19 pandemic, we partnered with CerTest to quickly develop a molecular test to help better understand and track this disease."

The BD MAX™ System is a fully integrated, automated platform that performs nucleic acid extraction and real-time PCR providing results for up to 24 samples across multiple syndromes in less than three hours. BD offers an extensive menu of tests on the system covering health care associated infections, respiratory infections, sexually transmitted infections, gastrointestinal infections and women's health. BD offers a suite of open system reagents for the BD MAX™ System that enables labs to fully automate and streamline their Lab Developed Tests.

"Speed is of the essence when responding to what the World Health Organization has declared a global health emergency," Nelson Fernandes, managing director of CerTest Biotec. "We hope this new test will boost capacity for monkeypox research, ultimately helping quell the spread of the disease."

As with all CerTest tests, the Monkeypox PCR Detection Kit for the BD MAX™ System is offered in a lyophilized format. Accordingly, the test will come in a tube that snaps into the test-specific position on the BD MAX™ ExK™ TNA extraction strip, which is supplied by BD.

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 75,000 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 seven business units offering one of the widest portfolios for human In Vitro Diagnostic and Pharma. 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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