NEWS
BIVDA launches white paper on genomics potential
The British In Vitro Diagnostics Association (BIVDA) has published a new independent white paper, ‘Leveraging advanced diagnostics to realise the UK’s potential in genomics’ which examines the UK genomics landscape, with a focus on patient access to genomic testing. Improved access to genomics diagnostics has the power to transform healthcare and provide several societal benefits to the UK. By optimising diagnosis and treatment, personalised healthcare pathways can be implemented, empowering patients to better prevent future illness and access the most effective, bespoke therapies. However, while the UK is positioned as a world-leading pioneer in genomics innovation, patient access to genomic testing remains
suboptimal. For example, the UK currently
ranks 19th in Europe for uptake of
next-generation sequencing in non-small cell lung cancer. The question therefore arises: how can the UK’s potential in genomics be unlocked? The independent report, undertaken by Charles River Associates under commission for BIVDA, has identified a series of reasons for limited access to genomic testing for UK patients, while also recognising opportunities to improve the current situation.
Regulatory issues, a lack of centralised guidance on the applicability of different funding pathways and underdeveloped infrastructure to increase testing capacity are all persistent issues which currently hamper the UK genomics climate. Establishing critical partnerships across both the public and private sector, alongside the enactment of policy change, can begin to erode these barriers and improve the adoption of, and access to, genomic testing for UK patients. Visit
bit.ly/PIP-BIVDAgenomics to read the full white paper.
EDITOR’S COMMENT A changing landscape
Welcome to the June issue of Pathology in Practice, marking the halfway point of the year. Where has 2023 gone I hear you ask? I don’t have the answer but at least I can console myself with the thought – thanks to publishing deadlines – that it’s still May (just) as I write.
Just a few weeks ago the Department of Health and Social Care laid a new statutory instrument in Parliament amending the current UK Medical Device Regulations 2002. When it comes into force later this month it will be the first of a tranche of legal texts which will make up the new UKCA regulatory structure for medical devices and IVDs. What this publication does is to extend the current framework beyond the previous deadlines, with the aim of both the European and GB sides to avoid any potential shortages or delays in products reaching the market. PiP is very grateful that BIVDA’s Head of Regulatory Affairs Ashleigh Batchen has continued to contribute to this magazine on the subject, and her article on this latest development can be found on page 23. To ensure you know how it could affect equipment and devices in your laboratory it is a must read.
Also during May the BSMT held its Annual Microbiology Conference, at the now familiar surroundings of the RAF Museum in Hendon, North London. The combined might of the BSMT committee
has come together, under the leadership of new Chair Dr Mark Wilks, to produce a report on the day, which starts on page 17. The conference also marked the stepping down of previous Chair Dr Valerie Bevan, who has served the Society with distinction for many years in a variety of roles, with Mark paying tribute to her dedication at the start of the day. As we move into the second half of
the year, thoughts inevitably turn to IBMS Congress, taking place in September. This issue we look at the Plenary programme, as well as highlighting something different on offer for biomedical support staff. Within digital pathology, the headline
makers are often new high-capacity scanners, or the latest AI-enhanced software. One aspect of this fast-growing market that is easily overlooked is storage. On page 27 of this issue Imogen Fitt of healthcare research firm Signify looks at the options available for storing digital data, as well as its potential for further use.
Also in this issue we look at a new point-of-care device to assess critical bleeding, a detailed consideration of blood culture best practice – including pre-analytical KPIs, and the Literature Update feature showcases recent publications considering the use of bacteriophages against bacterial infection. Enjoy the issue!
andy.myall@
pathologyinpractice.com
Extended acceptance of CE-marked medical devices in Great Britain
A statutory instrument has been laid in the UK Parliament, which will enable an extended timeframe for acceptance of CE-marked medical devices on the Great Britain market, the MHRA has announced. Subject to Parliamentary approval this will mean that CE-marked medical devices will be accepted beyond the current deadline of 30 June 2023.
This will support the ongoing, safe supply of medical devices to Great Britain and is designed to ease the transition to a future strengthened regulatory framework for medical devices. The government will ensure that there is a proportionate, phased approach to the implementation of the future regulatory framework, which supports system readiness and minimises the risk of supply disruption for UK patients.
WWW.PATHOLOGYINPRACTICE.COM JUNE 2023 The MHRA says that it is aiming for
the revised framework to now apply from July 2025. In setting this timeline it has taken on board feedback from external stakeholders, such as concerns about limited capacity of conformity assessment bodies. In March this year, the EU took steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation (EU MDR), including extending validity of certain CE certificates.
The MHRA guidance has been updated
to reflect these planned changes to the acceptance of CE marked medical devices in Great Britain. For more information, see our feature from BIVDA on page 23 of this issue.
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