BioMérieux announced on Friday that it has obtained CE marking for an assay to detect two biomarkers associated with mild traumatic brain injury (mTBI).

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

Recently, Autobio's hepatitis B virus surface antigen (HBsAg) detection kit (magnetic particle chemiluminescence method) successfully passed the European clinical assessment and obtained the first EU CE IVDR Class D certification in China.

Medtronic has received a CE mark for its continuous glucose monitoring (CGM) device, Simplera, allowing the device to be marketed in the European Union.

Geneseeq Technology Inc. has announced that three of our next-generation sequencing (NGS)-based cancer genetic testing kits, GENESEEQPRIME NGS Tumor Gene Detection Kit (GeneseeqPrime ™), GENESEEQ Homologous Recombination Deficiency Detection Kit (GeneseeqPrime™ HRD), and GENESEEQ Blood Cancer Gene Detection Kit (Hemasalus™ DNA/Hemarna™ RNA), have obtained the European Union’s CE Mark approval.

Recently, Ustar and Hangzhou Biotest Biotech received the IVDR CE certificate from TÜV SÜD, a notified body designated under the EU's IVDR.

DiaSorin said Tuesday that it has secured CE marking for an immunodiagnostic assay to aid diagnosis of severe conditions including sepsis, septic shock, kidney diseases, and lower respiratory and urinary tract infections, and the firm is launching the assay in Europe.

Cepheid announced that it has received the CE mark for Xpert NPM1 Mutation, a molecular in vitro diagnostic test for the quantification of mutant NPM1 mRNA transcripts (types A, B and D in exon 12) in peripheral blood specimens from patients with Acute Myeloid Leukemia (AML).

MGI Tech said last week that it has signed the EU Declaration of Conformity for its DNBSeq-G99 sequencer, granting the instrument CE marking under Europe's new In Vitro Diagnostic Regulation (IVDR).

BGI Genomics said on Friday that its multiplexed test for SARS-CoV-2, influenza A, and influenza B is now included in the Australian Register of Therapeutic Goods.