BD (Becton, Dickinson and Company) (NYSE: BDX) a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Conformité Européenne (CE) marking in the European Union for its Enteric Bacterial Panel* (EBP) and Enteric Bacterial Panel plus* (EBP plus) for the BD COR™ System.

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

BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced a new self-collection solution for HPV testing in markets outside the United States. This new innovation simplifies at-home sample collection for patients and further automates lab processing using high-tech robotics with the BD COR™ System.

CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced new innovations and products that will be featured at The American Society for Histocompatibility and Immunogenetics (ASHI) 2025 Annual Meeting, held October 6th to 10th in Orlando, Florida. The company also announced that its AlloSeq® Tx and QTYPE® products have received certification for compliance to the In Vitro Diagnostic Regulation (IVDR) in the European Union.

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

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that it has achieved CE-IVDR certification for its full portfolio of QIAstat-Dx syndromic testing systems and panels, including an expanded Meningitis/Encephalitis (ME) Panel that sets a new benchmark in the diagnosis of central nervous system (CNS) infections.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received CE IVDR approval for two label expansions for its VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx* assay. HER2 is a receptor protein expressed in a variety of cancers and serves as a predictive biomarker to help determine if a patient will respond to HER2-targeted therapy.

Agilent Technologies Inc. (NYSE: A) today announced that its MMR IHC Panel pharmDx (Dako Omnis) has received class C companion diagnostic (CDx) certification under EU in vitro diagnostic regulation (IVDR)1 as a CDx test for colorectal cancer. MMR IHC Panel pharmDx (Dako Omnis) is indicated as an aid to identify mismatch repair (MMR) deficient CRC patients eligible for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab). MMR IHC Panel pharmDx (Dako Omnis) is approved for exclusive use with the Agilent Dako Omnis automated staining solution.

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.