Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that Signatera has received certification as a Class C device under the European Union’s In Vitro Diagnostic Regulation (IVDR).

Beckman Coulter Diagnostics, a global leader in clinical diagnostics and a Danaher company, today announced it received CE Mark under IVDR for its Access p-Tau217 assay, a blood test designed to support clinical evaluation of amyloid pathology in patients with signs and symptoms of cognitive decline. The company also introduced its high-specificity Access BD-pTau217 Research Use Only (RUO) assay at the Alzheimer's Association International Conference (AAIC) 2026 in London.

We are proud to announce that Hartwig Medical Foundation has received CE certification under the European In Vitro Diagnostic Regulation (IVDR) for Hartwig Medical OncoAct (OncoAct), our software solution for cancer diagnostics based on Whole Genome Sequencing (WGS) in solid tumors.

altona Diagnostics today announced that its FlexStar® STI panel has obtained CE marking under Regulation (EU) 2017/746 (IVDR). This completes the IVDR transition for the company’s modular and adaptive STI testing portfolio, enabling laboratories to configure customizable multiplex panels for up to 7 sexually transmitted pathogens in a single sample.

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

Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today the European Union In Vitro Diagnostic Regulation (IVDR) approval of several label expansions for the VENTANA® MMR RxDx Panel, an immunohistochemistry (IHC) companion diagnostic test that aids in identifying a cancer patient’s mismatch repair (MMR) status. MMR is a process that scans a person’s genetic code and fixes errors to prevent mutations that can lead to cancer. The test evaluates a panel of MMR proteins in tumours to provide this important treatment information to clinicians.

Seegene, a global molecular diagnostics company, announced the European launch of its new antimicrobial resistance (AMR) testing product, Allplex™ MDRO Assay, which is CE marked under the EU In Vitro Diagnostic Regulation (IVDR). The assay is designed to support the detection of multidrug-resistant organisms (MDROs) associated with healthcare-associated infections (HAIs).

Cepheid, a Danaher company, announced today that it has received CE marking under the in vitro medical device regulation (IVDR) for the Xpert GI Panel. This multiplex PCR test is designed to enable fast, accurate detection of 11 clinically relevant gastrointestinal (GI) pathogens from a single patient sample. Leveraging Cepheid's 10-color multiplexing technology on its GeneXpert® systems, the test offers a robust solution for simplifying GI testing workflows and delivering meaningful answers to clinicians.

H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that Fujirebio Europe N.V. has obtained a CE certificate of the Lumipulse G pTau 217 Plasma assay under the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). This CLEIA (chemiluminescent enzyme immunoassay) test allows for the quantitative measurement of Tau phosphorylated at threonine 217 (pTau 217) in human plasma (K2EDTA).

Meridian Bioscience, Inc., a leading global provider of diagnostic testing solutions and life science raw materials, today announced that a broad portfolio of its Alethia molecular assays has successfully achieved CE marking under the European In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.