NEWS
WHO guidance on diagnostics for newborns
The World Health Organization (WHO) has released a new target product profile to guide the development of in vitro diagnostic tests for serious bacterial infections in newborns and young infants, including neonatal sepsis – a leading cause of infant deaths globally. Each year, an estimated 2.3 million
newborns die, with low- and middle- income countries bearing the greatest burden. Roughly 15% of these deaths are due to sepsis. Evidence suggests that 84% of newborn deaths due to infection could be prevented through early diagnosis and appropriate clinical management. Current diagnostic methods for serious bacterial infection, including bacterial sepsis, are often inadequate, inaccessible, or unaffordable in both hospital and non-hospital health facilities. Diagnostic methods, such as blood cultures and molecular diagnostics, face significant limitations, including low sensitivity and long turnaround times, high costs and infrastructure requirements, and inadequate performance. “This new target product profile outlines the essential features needed in diagnostic tools to improve clinical decision-making, reduce unnecessary antibiotic use and prevent antimicrobial resistance, especially in low-resource settings where the burden of neonatal sepsis remains critical,” said Dr Silvia Bertagnolio, Head of the Antimicrobial Resistance Surveillance, Evidence and Laboratory Strengthening Unit at WHO. The target product profile defines the essential and desirable characteristics of in vitro diagnostic tests to support early, accurate diagnosis among infants aged 0–59 days. The tests are designed to address two priority use cases: diagnosis occurring in primary health care settings and in higher level healthcare facilities The target product profile was developed by the WHO Department of Antimicrobial Resistance through a strong collaboration with the Department of Maternal, Child Health and Ageing, and with the contribution of WHO Research for Health Department. WHO acknowledges the substantial contribution of many partners, especially FIND, and the essential role of the target product development group members.
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Three London Trusts join NPIC digital pathology network
The National Pathology Imaging Co- operative (NPIC), based at Leeds Teaching Hospitals NHS Trust has announced that three major NHS Trusts in North Central London have successfully gone live on the NPIC digital pathology network, marking an important milestone for digital healthcare innovation across the UK. The Trusts, University College London Hospitals NHS Foundation Trust, Royal Free London NHS Foundation Trust (part of the joint venture partnership with The Doctors Laboratory which forms Health Services Laboratories), and Whittington Health; collectively serve a patient population of approximately 1.8 million across some of London’s most diverse and high-demand healthcare communities. Their integration onto the NPIC digital pathology platform represents a transformational step towards scaling cutting-edge digital pathology nationwide and will help to bring the latest technology advancements to increase efficient analysis and diagnosis for patients. This expansion to London, establishes NPIC as the first digital pathology network in the UK to move beyond traditional regional pathology networks. By joining forces with three of London’s leading NHS Trusts, NPIC connects leading pathologists and laboratory experts across England on a single national network. This creates unprecedented opportunities for NHS
organisations to share expertise, and deploy digital innovation at scale. Through the NPIC network, pathologists
at these Trusts will be able to seek second opinions from subspecialty experts across the country, supporting faster, higher-quality decision making. Multidisciplinary Team (MDT) meetings become more efficient, with digital images and reports shared instantly between sites, reducing delays in complex case reviews and costs associated with transportation of glass slides. Professor Darren Treanor, NPIC
Programme Director commented: “We are very pleased to welcome North Central London to the NPIC community. This is a significant milestone in our programme, demonstrating that it is possible to create a national digital pathology system that crosses regional boundaries. We hope this marks the first steps towards other regions joining our national system, so many more patients and pathologists can share the benefits of our national programme.”
Expansion for NHS cancer vaccine trials
Patients with advanced head and neck cancers in England will be fast-tracked into a trial of a new cancer vaccine, as the NHS expands its world-leading trial ‘match- making’ service.
The investigational cancer vaccine uses mRNA technology to help the immune system recognise and kill cancer cells containing human papillomavirus proteins. More than 100 patients with advanced head and neck cancer in England will be matched to the trial, running at 15 NHS hospitals over the next year, supported by the NHS’ Cancer Vaccine Launch Pad (CVLP).
This is the third cancer vaccine trial to be run through the NHS Cancer Vaccine Launch Pad, coordinated by the Southampton Clinical Trials Unit, which has already helped refer around 550 patients to
trials of vaccines for bowel and skin cancers. The first head and neck cancer patients in England have received the investigational mRNA cancer vaccine in the clinical trial, known as AHEAD-MERIT (BNT113-01), with more patients to soon be enrolled at their nearest NHS hospital. The investigational cancer vaccine is designed to encode two proteins that are frequently found in head and neck squamous cell cancers associated with human papillomavirus (HPV-16), the most common type of head and neck cancer (accounting for 95% of these types of cancers), with the vaccine training the immune system to fight the cancer. NHS England is partnering with life sciences company BioNTech to help identify potentially eligible patients to refer to NHS hospitals running the clinical trial.
SEPTEMBER 2025
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