altona Diagnostics has announced that the CE-IVD marking under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) for all AltoStar^® PCR kits intended for monitoring of transplant patients will be completed during spring 2026. This milestone illustrates altona Diagnostics’ long-term commitment to regulatory excellence and clinical reliability.

altona Diagnostics GmbH announces the launch of the AltoStar^® HDV RT-PCR Kit 1.5 (CE-IVD), a new PCR test for the detection and quantification of hepatitis delta virus (HDV) specific RNA in human EDTA plasma and serum. This launch marks a unique milestone in molecular diagnostics: altona Diagnostics now provides the first and only complete automated CE-IVD PCR portfolio covering all five hepatitis viruses (A, B, C, D, and E).

In the fall of 2024, altona Diagnostics received the certificate for compliance with all applicable requirements of the In Vitro Diagnostic Medical Devices Regulation (IVDR; EU 2017/746) for their PCR testing products. altona can now launch CE-IVD marked products under the IVDR. The first assay to be launched will be the AltoSta^® Parvovirus B19 PCR Kit 1.5 in early January 2025, followed by a large set of AltoStar^® assay products in the first and second quarter of 2025.

altona Diagnostics GmbH, a leading developer and manufacturer of in vitro diagnostic PCR tests and automation solutions, announces a leadership transition. Dr. Ulrich Spengler and Dr. Markus Hess, the current General Managers, are transferring the management responsibilities to Dr. Sönke Friedrichsen and Hans Kuhn.

altona Diagnostics has announced a partnership with Velsera to customize and incorporate Velsera’s AI-based software platform into the AltoStar^® Workflow. The integrated solution utilizes Velsera’s FastFinder Analysis, with the resulting solution for automated Real-Time PCR infectious disease testing set to be available to users of the AltoStar^® Workflow in the second half of 2023.

altona Diagnostics GmbH announced the launch of the RealStar^® Zoonotic Orthopoxvirus PCR Kit 1.0*, a real-time RT-PCR based reagent system for the detection of zoonotic (non-variola) Orthopoxvirus species specific DNA – including monkeypox virus DNA of the Central and West African strains.