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IVD

This page shows the latest IVD news and features for those working in and with pharma, biotech and healthcare.

Oxford University, Prenetics to advance COVID-19 rapid testing for other infectious diseases

Oxford University, Prenetics to advance COVID-19 rapid testing for other infectious diseases

So far, the rapid test for SARS-CoV-2, the virus which cause COVID-19, has received CE-IVD approval in Europe and Medicines &Healthcare products Regulatory Agency (MHRA) approval in

Latest news

  • FDA okays Roche’s COVID-19 diagnostic test FDA okays Roche’s COVID-19 diagnostic test

    Roche said a CE-IVD test is also available in markets accepting the CE mark, for patients with symptoms of COVID-19 in affected areas. ... CE marking indicates that an in vitro diagnostic (IVD) can be legally commercialised in the European Union.

  • Roche and Illumina partner on genomics for cancer diagnostics Roche and Illumina partner on genomics for cancer diagnostics

    Roche plans to develop, manufacture and commercialise its Avenio IVD test kits for both tissue and blood use on Illumina’s Next Seq 550Dx system, while Illumina continues to sell the

  • NHS could save £7bn with greater diagnostics use NHS could save £7bn with greater diagnostics use

    Report suggests IVD tests could be key to big savings. The NHS could shave up to £7bn off its estimated £22bn deficit by 2023 if it takes advantage of diagnostic tools, ... The report specifically evaluated the savings of three existing IVD tests -

  • Industry welcomes European diagnostics regulations Industry welcomes European diagnostics regulations

    scandal. The European Biopharmaceutical Enterprises (EBE) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) voiced qualified support for the new IVD regulations. ... However, the two trade bodies anticipate the added

  • BioSure UK's home HIV test goes on sale in the UK BioSure UK's home HIV test goes on sale in the UK

    The single use, in vitro diagnostic (IVD) device is said to be 99.7% accurate from three months after suspected exposure to the infection and provides an indication of personal HIV

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Latest Intelligence

  • Brexit talks threaten supply of medical technologies Brexit talks threaten supply of medical technologies

    The timing is far from ideal. EU Member States have adopted new In Vitro Diagnostics (IVD) and Medical Devices (MD) Regulations. ... As this is a significant overhaul of the existing EU directives, authorities and companies have five years to adapt to

  • Deal Watch table for September 2013 Deal Watch table for September 2013

    Licence. Diagnostic products IVD. 75. Merck &Co / AstraZeneca. Licence. WEE1 kinase (MK-1775) for ovarian cancer.

  • Pharma deals during September 2013 Pharma deals during September 2013

    Strengthening another of its business units, Roche's diagnostic arm announced a licensing deal with Pacific Bioscience for human in vitro diagnostic (IVD) gene sequencing technology, paying $35m upfront and additional

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