The test allows for simultaneous detection of multiple viruses on a sample-to-answer platform designed for immunocompromised patients.
GeneProof announced the availability of its Cytomegalovirus (CMV) MC Polymerase Chain Reaction (PCR) Kit under the European Union (EU) In Vitro Diagnostic Regulation (IVDR).
The assay, available on the myCROBE platform, meets the requirements of Regulation (EU) 2017/746. The launch supports a line of immunocompromised/transplant PCR assays designed for clinical laboratories managing complex infections.
The myCROBE system provides sample-to-answer automation and allows for the customization of patient panels. The platform now enables the simultaneous detection of several IT viruses, including CMV, Epstein–Barr virus, human herpesvirus 6/7, human herpesvirus 8, Varicella-zoster virus, herpes simplex virus 1/2, BK Virus, and JC Virus.
“Achieving IVDR availability for our CMV assay on myCROBE reflects GeneProof’s ongoing investment in regulatory excellence and diagnostic innovation,” says Erik Allen, ceo of NuvinkaDx, in a release. “This menu expansion with the myCROBE platform strengthens our ability to support laboratories managing complex infections in transplant settings, where rapid and accurate pathogen detection is essential for patient management.”
The expansion follows a 2025 announcement regarding improved extraction and the availability of sexually transmitted infections assays for the same platform.
The kits are intended for professional use in clinical laboratories. They are available to customers across Europe and in other regions that recognize IVDR-certified diagnostics.
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