GeneProof Announces CMV IVDR Launch on the myCROBE™ Fully Automated System for Transplant Care
Brno, Czechia, April 02, 2026 (GLOBE NEWSWIRE) -- GeneProof, a molecular diagnostics manufacturer and part of NuvinkaDx, announced several significant product and regulatory milestones.
The GeneProof Cytomegalovirus (CMV) MC PCR Kit is now available under the European Union’s In Vitro Diagnostic Regulation (IVDR) on the myCROBE platform. The assay meets the stringent requirements of Regulation (EU) 2017/746, reinforcing GeneProof’s commitment to delivering high-quality, compliant molecular diagnostic tests for clinical laboratories.
The launch of the CMV IVDR assay on myCROBE supports the recently launched line of Immunocompromised/ Transplant (IT) PCR assays on GeneProof’s myCROBE platform in Europe. Designed for sample-to-answer automation and complete flexibility in customizing patient panels, myCROBE now enables simultaneous detection of key IT viruses, including Cytomegalovirus, Epstein–Barr virus, Human herpesvirus 6/7, Human herpesvirus 8, Varicella-zoster virus, Herpes simplex virus 1/2, BK Virus, and JC Virus.
These launches build on GeneProof’s earlier 2025 announcement of improved extraction and availability of Sexually Transmitting Infections (STI) assays for the myCROBE platform, significantly expanding the menu.
“Achieving IVDR availability for our CMV assay on myCROBE reflects GeneProof’s ongoing investment in regulatory excellence and diagnostic innovation,” said Erik Allen, CEO of NuvinkaDx. “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.”
GeneProof myCROBE kits are intended for professional use in clinical laboratories and are available immediately to customers across Europe and other regions recognizing IVDR-certified diagnostics. For more information, please visit www.geneproof.com.
About NuvinkaDx
ALPCO was founded in 1991 as an importer and distributor of immunoassay-based products for the North American life science markets. The company has since evolved into a leading producer of novel immunodiagnostic reagents for specialty testing laboratories.
In 2022, ALPCO merged with GeneProof, a Czech Republic-based provider of specialty molecular diagnostic solutions. Founded in 2005, GeneProof offers a portfolio of more than 50 IVDD and 6 IVDR PCR test kits for infectious diseases and genetic mutations, as well as a suite of proprietary instrumentation for clinical laboratories of all sizes.
In 2024 the holdings company for both organizations rebranded to NuvinkaDx. For additional information, please visit www.alpco.com and www.geneproof.com.
Kim DiBurro NuvinkaDx 800-592-5726 kdiburro@nuvinkadx.com
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