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New prostate cancer test “cuts biopsies by 50%” in US real-world use

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Test has demonstrated 94 per cent accuracy in identifying prostate cancer, compared to 55 per cent from traditional PSA tests, along with significant reduction in false positives.

Kearney Urology Center, a specialist clinic in Nebraska, USA, has reported a 50 per cent reduction in biopsies since adopting a new blood test for prostate cancer. The reduction is credited to the adoption of the EpiSwitch® PSE, which has helped reduce the high number of false positives associated with the standard prostate-specific antigen (PSA) test.

EpiSwitch is the culmination of a ten-year British collaboration between Imperial College, Imperial NHS Trust, University of East Anglia and Oxford Biodynamics, itself a spin off from Oxford University.

There is currently no NHS prostate cancer screening programme in the UK. The UK National Screening committee advises against a national screening programme for prostate cancer due to the low sensitivity of the PSA test; approximately 15 per cent of men who do have prostate cancer do not have a raised PSA level.

Guidance for primary care is provided through the Prostate Cancer Risk Management Programme, and men over 50 (or over 45 for men at higher risk) are eligible to ask for a PSA test from their GP, however GPs are not recommended to proactively engage men in PSA testing, in part due to the test’s low sensitivity and tendency to produce false positive results. As many as three quarters of men with a high PSA do not have cancer. This means a significant number of men undergo the pain and potential side effects of unnecessary biopsies.

EpiSwitch PSE increases the accuracy of the PSA test from 55 per cent to 94 per cent and cuts false positives from 75 per cent to just 7 per cent.

Dr Alexandre Akoulitchev, CSO at Oxford BioDynamics, sad: “Having first demonstrated high accuracy of detection of prostate cancer in the NHS PROSTAGRAM trial in the UK, the EpiSwitch PSE test is today undergoing fast adoption in the US, where it is reimbursed by Medicare and other insurers. PSE leads to a significant reduction of biopsies and overtreatments in the real-world practice of US clinics. There is much value in this test, as recognised by clinical and private health-care institutions in both the US and UK today. Extending access to the general public in the UK would be subject to the NHS and National Screening Committee.”

Dr. Garrett Pohlman, Urologist at Kearney Urology Center, said: “I cannot imagine running my practice without EpiSwitch PSE; it’s a game changer. EpiSwitch increases the accuracy of the PSA test from 55 per cent to 94 per cent and cuts false positives from 3 in 4 to less than 1 in 10. Since adopting this test, I have cut the number of biopsies in half, allowing men who have tested negative for prostate cancer to avoid the pain and potential side effects of an unnecessary intervention.”

EpiSwitch is available privately from Goodbody Clinic and The London Clinic, the private hospital which diagnosed King Charles’ cancer when he was admitted for treatment to his prostate. In the US, the test is reimbursed under its own reimbursement code by several US insurers including Humana, UnitedHealthcare, Medicare and Optum Health. EpiSwitch PSE is not currently available on the NHS.

According to a Prostate Cancer Research report: “This (EpiSwitch) test combines the PSA test with a DNA test, resulting in substantially improved accuracy. Additionally, the test is minimally invasive and has the potential to reduce or eliminate the downsides of the PSA test, such as the high rate of false positives. The timing is ideal to explore innovative screening strategies and consider their benefits to patients, their loved ones and society as a whole.”

Mathias Winkler, Consultant Urologist and Surgeon at Charing Cross Hospital and Imperial College London, added: “The PSA test turns up very few cases of cancer and huge numbers of men are subjected to MRI scans and biopsies, as well as the worry that goes with that, and then it turns out they don’t have cancer.

“PSE is a diagnostic prostate cancer test with unprecedented accuracy. Nine of 10 cancers are found compared to 3 of 10 with PSA alone. Likewise, false-positive results are reduced avoiding unnecessary anxiety and expense.”

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News, Secondary Care

Breakthrough infection test to tackle antimicrobial resistance on target for 2025 NHS availability after positive trial results

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Trial of RNA-based host response analytics technology shows up to 95 per cent accuracy in ruling out lower respiratory tract infection.

UK medtech company, Presymptom Health, has announced positive results from a clinical trial aiming to tackle antimicrobial resistance. The trial, called PRECISiON, was designed to assess the performance of Presymptom Health’s technology in the management of infection and sepsis in patients presenting to emergency departments with respiratory infection.

Accurate infection diagnosis, by identifying patients who don’t require antibiotics, is crucial to saving lives and to tackling antimicrobial resistance, which has been labelled a global emergency by UK government health officials. Failure to address the problem of antibiotic resistance could result in an estimated 10 million deaths per year globally by 2050 and could cost the global economy £66 trillion.

As part of the PRECISiON clinical trial, which was conducted between May 2021 and April 2024 at Portsmouth Hospitals University NHS Trust and eight other NHS sites, Presymptom Health assessed the performance of its InfectiClear® diagnostic product. Early results show the InfectiClear® diagnostic product may have >95 per cent accuracy at ruling out lower respiratory tract infection, a significant improvement over standard of care.

The core of the InfectiClear® technology lies in RNA-based host response analytics, which examines the body’s response to an infection rather than attempting to detect the pathogen directly – a method that sets it apart from marketed tests available in the UK today. This approach provides an early, highly sensitive signal for infection or sepsis and avoids the delays and inaccuracies often seen with traditional tests, which can lead to unnecessary or incorrect treatments. These tests are platform agnostic, and will over time be offered on multiple different NHS PCR platforms, which were widely deployed during the COVID pandemic and are now often under-utilised.

“Antimicrobial resistance is a global crisis. If it’s not addressed, it will kill more people than cancer does today by 2050.”

Dr Iain Miller, CEO, Presymptom Health

Once ongoing validation work is complete and the product made available in the NHS, starting in 2025, this will enable clinicians to rule out infections earlier, and avoid unnecessary prescription of antibiotics in patients presenting with non-infectious inflammatory symptoms, such as fever and elevated heart rate or breathing. Such symptoms are not necessarily signs of active infection, and existing blood tests are not specific enough to diagnose infection or sepsis.

Further analysis of the trial results is ongoing, and full results will be announced later in 2025.

Dr Iain Miller, CEO of Presymptom Health, said: “Identifying the presence, or lack of, infection at the earliest possible opportunity is crucial to tackling the crisis. Current methods to detect infection are slow and inaccurate, leading to antibiotics being prescribed when they really don’t need to be. In fact, 20-70 per cent of the UK’s annual 35 million antibiotic prescriptions are unnecessary or inappropriate, depending on the clinical setting.

“This clinical trial, when combined with data from other NHS trials, was crucial to further evidencing the efficacy of the technology. It has also enabled us to collect vital data around infection from the 484 patients that took part. We are now looking to raise further funding to help us get this lifesaving technology into the NHS as a UKCA-accredited product in 2025 and to deliver further clinical trials across the NHS and overseas.”

Host response analytics: a new way to detect infection

Presymptom Health was established to exploit IP developed by scientists working at the UK Defence Science & Technologies Laboratory (Dstl), initially researching how to tackle biological threat infection, such as anthrax, plague and ebola. Ploughshare – the company that converts technology research created by government organisations into civilian applications – identified the innovation as having potential societal impact and spun it out from the UK Ministry of Defence in 2019.

Dr Paul Schmidt, Consultant at Portsmouth Hospitals University Trust and lead researcher for the study, said: “This study offered a fantastic opportunity to see how this leading-edge technology for recognising infection and sepsis, developed by UK Dstl scientists combining machine learning and molecular technologies, could benefit NHS patients.  I am excited to continue to work with Presymptom Health to unlock the huge potential of this technology”

Dr Schmidt led the collaborative development of the study design, working with Presymptom Health on behalf of Portsmouth Hospitals NHS Trust, the NHS Sponsor of the study.

Presymptom Health is developing a unique portfolio of blood tests powered by machine learning that accurately detect infection and sepsis up to three days before current standard of care. The technology has been trained on a dataset of blood samples collected over 15 years, encompassing thousands of cases, including patients who went on to develop infections and sepsis.

Earlier this year Presymptom Health was selected as one of only eight companies to be part of the Innovative Devices Access Pathway (IDAP) – a government initiative to bring new medical technologies to the National Health Service (NHS) to help with unmet medical needs.

Presymptom Health to launch a further clinical trial

Presymptom Health plans to run a follow-on 350-patient trial in 2025 to assess the accuracy and utility of InfectiClear® in patients with symptoms of respiratory and other infections. It is hoped that the results from this trial, named Precision 2, would help drive adoption at scale across the NHS.  The trial is being designed with inputs under the IDAP program from the NHS, the Medicines and Healthcare products Regulatory Agency, and NICE.

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News, Secondary Care

Optimising medication management: lessons from an NHS Trust

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Hardeep Bagga, Director of Pharmacy at University Hospitals Coventry and Warwickshire NHS Trust, discusses how best to manage the implementation of new technology following the success of digitalising pharmacy services.

University Hospitals Coventry and Warwickshire (UHCW) NHS Trust is one of the largest acute teaching Trusts in the UK, comprising University Hospital in Coventry and the Hospital of St Cross in Rugby, and working in partnership with Warwick University Medical School and Coventry University. It has more than 10,000 staff and delivers services across the West Midlands region. This includes hosting region-wide services such as the Coventry and Warwickshire Pathology Network and Bowel Cancer Screening programme.

In 2018, the Trust launched an ambitious target to begin a journey of digitising their medicines management systems, starting with a Trust-wide implementation of Automated Dispensing Systems to drive safe and legislative compliance with storage. At the time, medication storage was time and operationally intensive on pharmacy and nursing teams. The Trust was on a journey to establish Electronic Patient Records (EPR), and it was agreed that a solution was needed to bring together both challenges; improving medicines storage and security to fully leverage the power of a hospital EPR system.

Initially, we had to present a business case within the Trust, which included recognising the external and internal scrutiny required to ensure we had robust medicines storage; assessment of security, nurse-led audit work, as well as acknowledging the impact of medicines handling on Time to Care. A number of enthusiasts supportive of the programme were recruited from ICT, Nursing, Pharmacy and Estates teams.

Following a competitive tender process, we made the decision to partner with Omnicell UK, who provide advanced automation, data intelligence and professional services, in order to transform operational efficiency and improve patient experience in hospitals.

Omnicell initially worked with us on our first stage installation, which included introducing more than 70 Automated Dispensing Cabinets (ADCs) on wards, in theatres and clinics. Such was the scale of the operation that at the time, it was one of the largest and fastest European rollouts.

Unbeknown to us at the time of committing to the project, but we were inadvertently helping to prepare ourselves for the biggest healthcare challenge the NHS has ever witnessed – the Covid-19 pandemic. Since implementation, the Trust has improved management of medicines during shortages, taken waste out of operational delivery of the supply of medicines, informed teams around medicines safety during temperature deviations, and is now progressing towards closed-loop medicines administration.

Project and installation highlights include the following:

  • All wards and departments have automated dispensing systems for medication storage (72 units in total), including two in pharmacy for controlled drugs and after-hours support.
  • Medication Safety Officers (MSO) used a live view to track high demand, essential treatment medicines throughout Covid and beyond.
  • Temperature monitoring gives an overview of real time temperature of all stock areas to support informed decision-making during temperature deviations.
  • Digital ordering by automated dispensing systems has reduced nurse time handling medicines by using pharmacy team time saved from ordering medicines redeployed to fill cabinets instead of nurses.
  • Increasing breadth of stock holding as top up occurs thrice or more weekly, rather than just weekly, across the Trust.

Such was the success of the project, that over the entire pandemic, the wards never ran out of stock of essential Covid treatments by utilising this technology.

Essential elements in the change management process

An effective and well thought out change management process was crucial in gaining buy-in from internal stakeholders and in particular, the nursing team who would be day-to-day users and large beneficiaries of the new technology.

The Pharmacy team at University Hospitals Coventry and Warwickshire NHS Trust (9th from left: Hardeep Bagga)

Valuable best practice lessons can be taken from trusts such as ours, to help support the successful adoption of technologies across the healthcare sector. First and foremost, this includes the need to have a solid change management plan in place to drive employee engagement – employees have to be part of the planning as much as the execution.

Adaptations to technology also tend to go more smoothly when applied from the ‘bottom up’. This can be done by assigning and engaging ‘change champions’ or representatives within different departments. The key overriding factor remains: be the lead on the timeline and rules of the technology, but let your employees decide how to run the show.

A good way to start, as we did at UHCW, was to encourage internal stakeholders to make a list of their wishes and goals from the project at the outset. This was supported by a clear communication and adaptation strategy which emphasised the value and usage of digitalising and automating pharmacy services, and the impact this would have on internal teams, as well as our patients. This helped to ensure the implementation process went smoothly and served to remind us all of the end goal when at times, the project ate into our time or we hit a bump in the road.

It’s important to work closely with your technology partners to ensure effective communication. Omnicell was key to understanding our workflow, mapping this out to ensure systems benefited the way we work, as well as providing ongoing education and training. As partners on the project, the post ‘go live’ support, which included floor walking and handholding for ‘live day’ and the week afterwards, was imperative.

The project is by no means complete and currently we are working towards a key milestone which will be to link the ADCs and our robotic dispensing system to Oracle-Cerner. This will mean that our patient record system will provide a live/real-time view of what’s stocked in cabinets, as well as streamlining workflow and retrieving medications. All with enhanced security and removing process waste to support closed-loop administration.

More recently…

Further enhancing the Trust’s technology adoption, we recently installed two large dispensing robots in pharmacy – Tom and Jerry – with a joint capacity to hold more than 50,000 packs of medication. Importantly, they have allowed for the automation of nearly two million medication transactions which were previously ‘hand-picked’.  The time saved allowed a skill mix change within the department, releasing time for Medicines Management Assistants (MMAs).  As a result, MMAs are now working directly on wards, and utilising automated cabinets to improve patients’ medication journeys. Dedicated medicines returns units have helped drive the better use of medication and recycling of stock medication at a ward level. The impact has been staggering, saving large amounts in waste prevention.

In addition, all ward stock medication top-ups are now fully automated; the ward ADC sends a message to the robots at 6am and all ward boxes are picked and packed by the robots before the staff come into work. This process previously required manual picking and an accuracy check by another senior colleague, but is now fully automated.

The Pharmacy team last year celebrated winning the CEO Team Award at the Trust’s Outstanding Service and Care Awards (OSCAs), which is positive recognition of its digital transformation.

Find out more about the new MES initiative: Omnicell.co.uk or email: Sales-aa@Omnicell.com

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