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.

Since May 2022 cases of monkeypox have been confirmed in at least 12 countries, that are not endemic for monkeypox virus, e.g. in the USA, Canada, UK, Germany, Spain, and Australia. Due to this development, altona Diagnostics has received more and more requests from all over the world for PCR tests to detect this virus.

As part of the pilot project SCoPE (SARS-CoV-2 PCR examination), the feasibility of screening for SARS-CoV-2 using PCR analysis is being tested at two Hamburg day care centers. Day care center children and staff will be screened on a voluntary basis for infections with the SARS-CoV-2 coronavirus. The tests can help to determine the current risk of infection at day care centers and to prevent further infections, e.g. by targeted isolation measures.