The MDCC Unit in the Office for Life Sciences has put together a Q&A document covering an extensive range of issues including UKCA marking, cross-border trade and packaging requirements. Members can find it attached.

A new vision for the delivery of clinical research has been announced by the Government which is designed to improve the processes through which researchers can design and deliver their work. The vision will strengthen the UK’s renowned expertise in the research area and its position as a world-class country in terms of research standards. It is expected that patients and staff will benefit greatly from having research dedicated towards the improvement of their experiences in the NHS being...

BIVDA welcomes new Government research strategy BIVDA, the trade association for British in-vitro diagnostic companies, has welcomed the publication of the Government’s new research strategy ‘Saving and improving lives: the future of UK clinical research delivery’. The strategy sets out plans to strengthen the UK’s renowned expertise as a world-leader in designing and delivering medical and scientific research. It is built around 5 key themes:  Clinical research...

Three new Lighthouse Lab testing facilities have opened in Brants Bridge, Baltic Park and Plymouth, adding to the list of test processing sites across the United Kingdom. These labs will be working in partnership with NHS Test and Trace to identify new cases of coronavirus, thus ensuring that the chains of transmission are broken in communities. The labs are managed by local NHS trusts, and form the largest network of diagnostic facilities ever set about in British history. The Lighthouse Labora...

A new independent review has been launched by the Science Minister Amanda Solloway into how red tape can be cut to allow researchers to carry out their work better. The review will identify hurdles of UK research bureaucracy that hold the UK back in terms of securing a world-class research output. The study will be led by Professor Adam Tickell, Vice Chancellor at University of Sussex and delivers on the commitment by the UK Government in the strategic Research and Development Roadmap to minimis...

BIVDA Welcomes new EUCOPE – Charles River Associates report on advanced diagnostics  BIVDA, the UK trade association for in-vitro diagnostic companies, has welcomed the publication of a White Paper on Advanced Diagnostics by EUCOPE and Charles River Associates that puts forward concrete proposals to support understanding of the advanced diagnostics sector, the benefits it brings and related requirements for success . The health benefits of genomics and advanced genomic testing ar...

Please find attached the documents referred to in Helen's COO update on 19th March.

A new immunoassay biomarker diagnostic tool that is used in the detection of cancers caused by the human papilloma virus (HPV) has attracted investment of over €2 million. The company which produces it is a biotech innovation firm from Germany called Abviris Deustchland. The company says this is the first available blood - based test shown to be specific enough to aid in diagnosis of HPV. Further, the rapid flow test delivers its results within 20 minutes.The early investment in the product...

MICROSENSDX RapiPRO™ LAMP for SARS-CoV-2 RECEIVES CE MARK APPROVAL Pioneering British biotech MicrosensDx has announced that its RapiPRO™ LAMP SARS-CoV-2 test has received CE Certification.The business, an established molecular diagnostics innovator with a 20-year history in IVD development, is a recognised expert in Loop-mediated Isothermal Amplification (LAMP) testing, having developed proprietary tuberculosis (TB) diagnostics using the technology.MicrosensDx has revealed robu...

PulmoBioMed – a new medtech spin-out in the North East of England Launched with funding from Northumbria University and Innovate UK, and with its first product PBM-HaleTM in clinical trials in Europe, PulmoBioMed now seeks to close its £2.5 m initial equity capital raise. PBM-HaleTM, a Class 1 medical device, is designed to collect exhaled breath condensate samples in a non-invasive manner. The hand-held device captures a wide range of biomarkers including protein, RNA, DNA...