NEWS
A&E testing uncovers thousands of virus cases
New evaluation of NHS England’s emergency department opt-out testing has identified thousands of people living unknowingly with bloodborne viruses. The UK Health Security Agency has
recently published its evaluation report of the groundbreaking NHS emergency department (ED) opt-out testing programme – an integrated bloodborne virus (BBV) testing programme for HIV, hepatitis B and hepatitis C. The evaluation findings show the programme has identified thousands of people living unknowingly with bloodborne viruses, with many now being offered life- saving treatment for the first time. As part of blood tests taken during
emergency care in 34 EDs in areas with the highest HIV prevalence, people are automatically tested for HIV, hepatitis B, and hepatitis C unless they opt out. Those who receive a diagnosis are then offered treatment and support. The results demonstrate the
programme’s significant impact. Over the 33 months to 1 January 2025, it conducted over seven million BBV tests, representing around 50% of all BBV testing done in these areas during this period. It achieved an
uptake rate of around 70% among eligible people, demonstrating the effectiveness of the opt-out approach. The programme discovered: 3,667 new hepatitis B (HBV) diagnoses; 831 new hepatitis C (HCV) diagnoses; and 719 new HIV diagnoses. One in 240 people tested was found to have hepatitis B, highlighting the large number of people who are living with undiagnosed hepatitis B and the benefit of combined opt-out testing for BBVs in EDs. Similarly, one in 1,276 people tested was found to have HCV and one in 1,916 for HIV. Further benefits included care re-engagement including 291 people previously diagnosed with HIV who were subsequently re-linked to HIV care during the programme.
Major change for rare disease treatments
A new policy paper from the Medicines and Healthcare products Regulatory Agency (MHRA) commits the UK to major reform in treatments for rare diseases, with a new rulebook for rare therapies being prepared for publication next year. The UK regulator’s intentions to overhaul the rulebook for rare disease therapies in the UK are outlined in the paper, Rare therapies and UK regulatory considerations, which supports the ambitions of the Government’s life sciences strategy. Central to this reform will be tackling barriers which currently prevent life- changing rare disease therapies from reaching patients, like small patient numbers and difficult evidence generation, while maintaining safety. Around 3.5 million people in the UK – one in 17 – live with a rare disease. Yet fewer than 5% of rare diseases currently have an approved treatment. The average diagnostic journey takes 5.6 years, and 30% of affected children die before the age of five.
The new paper sets out how the MHRA is thinking to change this. It commits the UK to major reform and is a huge signal that significant change for rare disease patients is on its way. Supporting the development of the reforms is a newly formed Rare Disease Consortium, which includes patients and their representatives, academics and industry. While the framework won’t be published in full until next year, the paper today outlines some bold ideas, including whether an early, single approval could be issued for both a clinical trial application and marketing authorisation based on compelling but limited evidence. This approval would be granted with a strict safety monitoring plan with real-world evidence review at a set frequency. The paper also sets out: how to better
share evidence in the UK and globally to pool scarce data; the importance of strengthened post-market surveillance; and better health system alignment in the UK and internationally.
WWW.PATHOLOGYINPRACTICE.COM DECEMBER 2025 9
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