Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today PGDx elio™ tissue completeopens in a new tab has been CE-marked under the European Union's (EU) new In Vitro Diagnostic Regulation (IVDR). It is now the first and only test of its kind in the EU CE-marked for comprehensive solid tumor profiling. This marks a significant milestone in expanding access to personalized treatment options for the approximately 2.7 millionopens in a new tab people diagnosed with cancer every year in the EU.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received CE Mark for its Elecsys® pTau181 test to measure phosphorylated Tau (pTau) 181 protein which is an indicator of amyloid pathology, a hallmark of Alzheimer’s disease. The test, which has been developed in collaboration with Eli Lilly and Company, can be used by clinicians in conjunction with other clinical information to rule out Alzheimer’s disease as the cause of cognitive decline. This could avoid the need for further confirmatory investigation for patients testing negative.

Fulgent Genetics announced on Thursday that it has obtained the CE-IVDR mark for its germline next-generation sequencing service.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the introduction of its innovative Chest Pain Triage algorithm as part of the navifyⓇ Algorithm Suite. This groundbreaking algorithm is designed to more quickly and accurately detect Acute Coronary Syndrome (ACS) in patients presenting with chest pain, one of the most common reasons for Emergency Department (ED) visits. As EDs are typically one of the most crowded hospital units, leading to challenges to swiftly diagnose critical conditions, such as chest pain.4 This new algorithm was developed in collaboration with Universitätsklinikum Heidelberg.

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.