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.
Illumina may avoid an approximately 432 million euro fine related to its Grail takeover after an adviser to the Court of Justice of the European Union (ECJ) ruled in its favor Thursday.
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.
The European Commission (EC) has proposed an extension of the transition period for the IVDR, aiming to maintain the availability of essential healthcare products and ensure patient care.
Bruker has entered into an agreement with private equity firm PAI Partners to purchase EliTechGroup, PAI announced on Wednesday.
Virax Biolabs said on Thursday that it has formed an alliance with the University of Manchester and Northern Care Alliance Foundation Trust, a member organization of the UK's National Health Service, to investigate T-cell responses in long COVID-19 patients.
CACLP's initiative to launch an English/Chinese webinar for non-EU IVD players in next January is set to provide a crucial platform for understanding EU IVDR registration requirements.
Owkin announced on Tuesday that it entered into a collaboration with MSD — known as Merck in the US and Canada — to develop and commercialize microsatellite instability high (MSI-H) diagnostics for four types of cancer.
EliTechGroup announced on Thursday that it has received certification under Europe's In Vitro Diagnostic Regulations for multiple infectious disease tests.
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