Revvity, Inc. (NYSE: RVTY), today announced the launch of EUROIMMUN’s CE-marked Anti-Measles Virus ELISA 2.0 (IgG) to support the diagnosis of a measles virus infection or to determine the immune status against measles virus. EUROIMMUN’s Anti-Measles Virus ELISA 2.0 (IgG) is the first of several assays in development expanding EUROIMMUN’s serological infection diagnostics portfolio with validation for dried blood spots (DBS) as sample material in addition to serum and plasma.

AliveDx has obtained a CE mark under the EU’s in vitro diagnostic regulation (IVDR) for the AiPlex connective tissue disease (CTDplus) multiplex assay for use with its MosaiQ planar microarray platform.

South Korean diagnostic firm Noul said Wednesday that it has inked an agreement to launch its hematology and malaria testing tools in Europe through German lab chain Limbach Group.

Agilent Technologies Inc. (NYSE: A) today announced the issuing of a Class C companion diagnostic In Vitro Diagnostic Regulation (IVDR) certification for PD-L1 IHC 28-8 pharmDx (Code SK005). This CDx assay has previously been CE-IVD–marked for sales in the European Union and is now certified in accordance with the new EU Regulation for in vitro diagnostic medical devices (IVDR) 1. PD-L1 IHC 28-8 pharmDx is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution.

Agendia, Inc. today announced that it has obtained certification from the European Union (EU) In Vitro Diagnostic Medical Device Regulation (IVDR) for three products, including its MammaPrint® FFPE Microarray, BluePrint® FFPE Microarray, and MammaPrint and BluePrint NGS Kit. These products are classified as Class C under this regulation. This certification recognizes Agendia’s strict adherence to rigorous quality and safety standards and ensures the tests’ reliability and effectiveness in clinical settings across the EU.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

The European Parliament has agreed to adopt measures to delay certain deadlines of the In Vitro Diagnostic Medical Devices Regulation (IVDR) and to gradually roll out the European Database on Medical Devices (Eudamed), the European Commission said on Thursday.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Illumina said on Tuesday that it has received a decision from the European Commission that will prohibit the firm from keeping liquid biopsy maker Grail.

The world is in a "race against time" with the Omicron coronavirus variant, said European Commission President Ursula von der Leyen on Sunday, warning during a visit to Latvia that scientists and manufacturers will need weeks to fully understand the new variant.