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.
After the AltoStar® Parvovirus B19 PCR Kit 1.5 in 2024, the AltoStar® EBV PCR Kit 1.5 will be available as a CE-IVD marked kit under the IVDR in April 2026. Further ten AltoStar® PCR kits will follow until June 2026, ensuring continuity and confidence for customers across Europe and other IVDR-recognizing markets.
Simultaneously, altona Diagnostics makes AltoStar® Analysis available, an advanced software solution for automated PCR data interpretation.
Fully integrated into the AltoStar® Molecular Diagnostic Workflow, AltoStar® Analysis supports result analysis through intelligent automation, significantly reducing hands-on time while minimizing the risk of human error through standardized review and approval steps. As a secure, on-premises solution, it ensures data integrity while enabling reproducible, traceable results for clinical laboratories.
“This double achievement represents an important step forward in our AltoStar® roadmap,” says Dr. Sönke Friedrichsen, one of the General Managers of altona Diagnostics. “We are proud to begin 2026 with the successful IVDR transition of our AltoStar® transplant assays, while at the same time adding AltoStar® Analysis to further streamline our automated PCR workflow.”
About AltoStar® EBV PCR Kit 1.5
The AltoStar® EBV PCR Kit 1.5 is designed for the detection and quantification of Epstein-Barr virus (EBV) DNA in human EDTA and citrate plasma and human EDTA and citrate whole blood, supporting diagnosis of EBV infection and monitoring of the EBV viral load in individuals with EBV infection. It is not intended to be used to detect the presence of EBV in blood, blood components, cells, tissues, organs or any of their derivatives in order to assess their suitability for transfusion, transplantation or cell administration.
About altona Diagnostics
altona Diagnostics is a medical diagnostic company that develops and manufactures in vitro diagnostic tests for the PCR based detection of pathogens such as viruses, bacteria, or parasites. Headquartered in Hamburg-Altona, Germany, altona Diagnostics is privately owned and employs more than 350 people worldwide, thereof 300 in Hamburg, Germany. The company has been in the molecular diagnostics business for over 25 years and is ISO 13485 certified. altona Diagnostics sells its registered products to medical laboratories globally through subsidiaries and more than 40 distribution partners.
Molecular diagnostic tests from altona Diagnostics are based on real-time PCR technology. altona Diagnostics offers the AltoStar® Molecular Diagnostic Workflow, an automated solution that is complete with instrumentation, reagents, consumables, and software. Furthermore, the company’s product catalog contains over 50 CE-IVD marked PCR tests that are also compatible with many open real-time PCR platforms.
| For further information, please contact: | |
| Meike Thiel | Phone: +49 (0)40 5480676-0 |
| altona Diagnostics GmbH | Fax: +49 (0)40 5480676-10 |
| Mörkenstr. 12 | info@altona-diagnostics.com |
| 22767 Hamburg, Germany | www.altona-diagnostics.com |
More information about AltoStar® EBV PCR Kit 1.5 and AltoStar® Analysis.
Release date: 2026-04-16
Release date: 2026-04-16
You need to load content from reCAPTCHA to submit the form. Please note that doing so will share data with third-party providers.
More InformationYou are currently viewing a placeholder content from Turnstile. To access the actual content, click the button below. Please note that doing so will share data with third-party providers.
More InformationYou are currently viewing a placeholder content from Vimeo. To access the actual content, click the button below. Please note that doing so will share data with third-party providers.
More InformationYou are currently viewing a placeholder content from YouTube. To access the actual content, click the button below. Please note that doing so will share data with third-party providers.
More InformationYou need to load content from reCAPTCHA to submit the form. Please note that doing so will share data with third-party providers.
More InformationYou are currently viewing a placeholder content from Facebook. To access the actual content, click the button below. Please note that doing so will share data with third-party providers.
More InformationYou are currently viewing a placeholder content from Instagram. To access the actual content, click the button below. Please note that doing so will share data with third-party providers.
More InformationYou are currently viewing a placeholder content from X. To access the actual content, click the button below. Please note that doing so will share data with third-party providers.
More Information