BD, also known as Becton Dickinson and Co., together with CerTest Biotec, on Monday announced its newly developed molecular polymerase chain reaction assay for monkeypox virus is now commercially available globally, including in the U.S., for research use-only applications by laboratories.
The Franklin Lakes-based company is working to submit a clinical test for monkeypox virus for emergency used authorization as soon as possible, based on the guidance recently issued by the FDA.
“Even before the U.S. Department of Health and Human Services and Food and Drug Administration declared the ongoing monkeypox outbreak in the United States a public health emergency, we were working with CerTest to quickly develop a molecular assay to help better understand and track the disease,” Nikos Pavlidis, vice president of molecular diagnostics at BD, stated.
The BD MAX System family 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.
“This new test boosts capacity for monkeypox research and surveillance of this global health emergency,” Nelson Fernandes, managing director of CerTest Biotec said. “The value of the BD MAX open systems architecture and its ability to speed research and development continues to be critical.”