Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received the CE Mark for its Accu-Chek SmartGuide® continuous glucose monitoring (CGM) solution. This significant milestone paves the way for the solution to be made available to people living with type 1 and type 2 diabetes over the age of 18 on flexible insulin therapy.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch of its new analytical units, cobas® c 703 and cobas® ISE neo, for the cobas® pro integrated solutions, in countries accepting the CE mark. The cobas pro integrated solutions is a scalable and modular diagnostic platform designed for high-volume laboratories. The cobas c 703 and cobas ISE neo analytical units offer cutting-edge features to help address some of the key challenges faced by diagnostic laboratories worldwide such as shortage of qualified staff and space limitations.

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

Siemens Healthineers said on Monday that the firm has received CE marking for a prognostic blood test that the firm plans to launch later this year in Europe to aid the management of multiple sclerosis.

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.

Revvity's EUROIMMUN business, a leading provider of high-quality in-vitro diagnostic products, and ALPCO-GeneProof, a global leader in molecular diagnostics, jointly announced a strategic partnership to enhance the availability of GeneProof PCR kits throughout the European Union. This collaboration brings together EUROIMMUN's extensive distribution network and support infrastructure with ALPCO-GeneProof's innovative molecular diagnostic technologies.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the approval of the CE Mark for the VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx* to identify metastatic breast cancer patients with low HER2 expression for whom ENHERTU® (trastuzumab deruxtecan) may be considered as a targeted treatment. The test, which is branded PATHWAY in the United States, received US Food and Drug Administration (FDA) approval in October 2022. ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.

C-luminary Biotech was founded in 2018 and is headquartered in Chengdu, China, with a research and development center in Suzhou and industrial platforms in Sichuan and Hunan, is a professional enterprise engaged in the research, development, production, and sale of in vitro diagnostic products.

Werfen has received CE marking for its Aptiva antiphospholipid syndrome (APS) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) reagents, meaning the in vitro diagnostics can now be used in the EU.

Roche announced on Tuesday that it has received CE marking for a claim extension on its Elecsys Anti-Müllerian Hormone (AMH) Plus test.