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.

Dutch diagnostics firm MRC Holland said Friday that two of its blood-based assays for spinal muscular atrophy (SMA) have been certified under Europe's In Vitro Diagnostic Regulation (IVDR).

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

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.

Bosch Healthcare Solutions has obtained CE-IVDR marking for its Vivalytic Bacterial Meningitis PCR test running on the company's fully automated Vivalytic analysis platform.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the CE certification of the new cobas® 6800/8800 systems 2.0. The update significantly enhances the efficiency of laboratories by optimising resources, reducing downtime, consolidating test menus, and increasing throughput. These improvements ultimately promise a more streamlined diagnostics experience for healthcare professionals and their patients.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received CE Mark for its VENTANA® FOLR1 (FOLR1-2.1) RxDx Assay. This is the first immunohistochemistry (IHC) companion diagnostic test to be made widely available in Europe to aid in identifying epithelial ovarian cancer (EOC) patients who may be eligible for targeted treatment with ELAHERE® (mirvetuximab soravtansine). ELAHERE is a first-in-class antibody-drug conjugate (ADC) therapy developed by AbbVie for the treatment of FRɑ-positive platinum-resistant ovarian cancer.

bioMérieux, a world leader in the field of in vitro diagnostics, announces the CE-marking of VIDAS® VITAMIN B12 TOTAL, an automated quantitative test for use on the VIDAS® immunoassay instruments, for the measurement of total Vitamin B12 concentration in human serum or plasma.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the VENTANAⓇ CLDN18 (43-14A) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive CE Mark approval for determining CLDN18 protein expression in tumours of patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. These patients now may be eligible for treatment with Astellas’ targeted therapy VYLOYTM (zolbetuximab).

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its QIAstat-Dx syndromic testing systems and associated assays have received CE-marking under the European Union's new In-Vitro Diagnostic Medical Devices Regulation (IVDR).