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

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

Yourgene Health (part of the Novacyt group of companies), a leading international molecular diagnostics group, announces that it has received accreditation under the new EU requirements of the in vitro diagnostic regulation (IVDR) for the Yourgene® Cystic Fibrosis Base assay. The Yourgene Cystic Fibrosis Base assay is a Class C in vitro medical device under IVDR and is intended for use by healthcare professionals within a molecular laboratory environment.

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).

PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that its AISightⓇ Dx Image Management System (IMS) is In Vitro Diagnostic Regulation (IVDR) certified for use in primary diagnosis. The CE mark paves the way for the company's expansion in the European diagnostic pathology market, enhancing pathologists' interpretations and driving efficiencies and quality improvements within anatomic pathology laboratories.

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.

Roche announced this week that its Ventana PD-L1 (SP263) assay received a CE-IVDR label expansion for use as a companion diagnostic with Regeneron's Libtayo (cemiplimab) in combination with platinum-based doublet chemotherapy in lung cancer patients.

ELITechGroup is pleased to announce that they have obtained the IVDR certification for four new products including the brand new CMV RNA ELITe MGB Kit.

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