June 8, 2022 – CerTest Biotec and BD announced a collaboration to develop a molecular diagnostic test for the monkeypox virus.
As part of the collaboration, the assay will leverage the BD MAX™ open system reagent suite to validate the CerTest VIASURE Monkeypox CE/IVD molecular test on the BD MAX™ System. The assay will be available for BD MAX™ users and may help advance understanding of the global spread of the disease.
“Enabling labs to rapidly respond to unexpected challenges is the kind of evolving health care situations for which the BD MAX™ open system reagent suite is designed,” said Nikos Pavlidis, vice president of Molecular Diagnostics at BD. “Through our collaboration with CerTest and their ability to rapidly transfer assays on the BD MAX™ System, we will enable BD MAX™ System users around the world to access a test for the confirmation of monkeypox.”
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 healthcare associated infections, respiratory infections, sexually transmitted infections, gastrointestinal infections, and women’s health diagnostics. 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, and BD can partner with customers to develop complementary assays on the system.
Nelson Fernandes, Managing Director of CerTest BioTec, added “The strong capabilities of our teams to rapidly develop molecular assays as well our experience working with the BD MAX™ System enables us to accelerate the development of an assay and further build our collaboration with BD.”
As with all CerTest tests, the Monkeypox PCR Detection Kit for the BD MAX™ System will be 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.