CerTest Biotec will leverage the BD MAX molecular diagnostic system and its open system reagent suite to develop an RT-PCR detection kit for the monkeypox virus
The assay will use BD MAX open system reagent suite. (Credit: BD)
US-based Becton, Dickinson and Company (BD) has partnered with Spanish rapid diagnostic testing devices maker CerTest Biotec to develop a molecular diagnostic test for the monkeypox virus.
Under the collaboration, CerTest will develop the VIASURE Monkeypox CE/IVD molecular test using the BD MAX open system reagent suite, and validate it on the BD MAX System.
The BD MAX System is a fully automated platform for nucleic acid extraction and real-time PCR, providing results for up to 24 samples across multiple conditions, within three hours.
The assay, which will be available for BD MAX users, is expected to help understand the global spread of the disease, said the US-based firm.
BD molecular diagnostics vice president Nikos Pavlidis said: “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.
“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.”
BD offers a wide range of tests on its BD MAX System, covering, respiratory infections, sexually transmitted infections, gastrointestinal infections, and women’s health diagnostics.
Its suite of open system reagents will enable labs to fully automate and streamline their Lab Developed Tests and can develop complementary assays on the system.
CerTest will provide the Monkeypox PCR Detection Kit for the BD MAX System in a lyophilized format, similar to its other tests.
The test comes in a tube that fits into the test-specific position on the BD MAX ExK TNA extraction strip, supplied by BD.
CerTest BioTec managing director Nelson Fernandes said: “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.”
Established in 2002, CerTest Biotec is engaged in the development and manufacturing of in-vitro diagnostic medical devices.