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

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.

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

Dutch diagnostics firm MRC Holland said Thursday that its liquid biopsy test for Peutz-Jeghers syndrome has been certified under Europe's In Vitro Diagnostic Regulation (IVDR).

Agilent Technologies Inc. (NYSE: A) today announced its PD-L1 IHC 22C3 pharmDx (Code SK006) assay has received European IVDR certification for the use as a Companion Diagnostic (CDx) to aid in the identification of gastric or gastroesophageal Junction (GEJ) adenocarcinoma patients who may be eligible for treatment with KEYTRUDA® (pembrolizumab)1. PD-L1 IHC 22C3 pharmDx (Code SK006) is approved for exclusive use with the Agilent Autostainer Link 48 advanced staining solution. KEYTRUDA is an anti-PD-1 therapy developed by Merck (known as MSD outside the United States and Canada).

Dutch diagnostics firm Inbiome said Friday that it has received certification under the EU's In Vitro Diagnostic Regulation for a PCR-based test to aid the identification of more than 200 bacterial species from patient samples, with results within five hours.

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).

Dutch diagnostics firm MRC Holland said this week that five of its blood-based tests for hereditary breast and ovarian cancer (HBOC) syndrome have received certification under Europe's In Vitro Diagnostic Regulation (IVDR).

MRC Holland said Thursday that its blood-based assay for Temple, Kagami-Ogata, and Russell-Silver syndromes has received certification under Europe's In Vitro Diagnostic Regulation (IVDR).

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.