Fleming Initiative and Cepheid Launch Landmark Study of Rapid Testing for Drug-Resistant Infections

30-month real-world study at two London NHS Trusts to evaluate how rapid CPE screening can improve clinical practice and inform NHS and national AMR policy

LONDON and SUNNYVALE, Calif., June 12, 2026 /PRNewswire/ -- The Fleming Initiative, a partnership established by Imperial College London and Imperial College Healthcare NHS Trust to combat antimicrobial resistance (AMR), and Cepheid, a Danaher company, today announced the launch of TRACE-CPE, a two-and-a-half-year research study to improve testing for AMR, one of the greatest global health challenges.

This real-world study evaluates how rapid molecular screening for carbapenemase-producing Enterobacterales (CPE) can improve infection prevention and control, support effective use of NHS resources and service delivery, protect patients and help inform national screening policy. The study will be at two of the hospitals run by Imperial College Healthcare NHS Trust and Guy's and St Thomas' NHS Foundation Trust, two of the largest NHS Trusts in England.

The TRACE-CPE study is delivered through a partnership between the Fleming Initiative and Cepheid, first announced in September 2024 at an event aligned with the UN General Assembly High-Level Meeting on AMR. Cepheid joined the Initiative as its first diagnostics partner, with a substantial, long-term commitment to collaborative scientific and clinical research as well as policy development and advocacy. This is aimed at strengthening and expanding the use of diagnostics in antimicrobial stewardship and the control of resistant infections.

CPE is one of the most urgent threats in the AMR crisis, one of the greatest health challenges of our time. CPE is a bacteria resistant to most antibiotics, including the carbapenems used as a last-resort treatment for serious infections, and classified by the World Health Organization (WHO) as a critical-priority pathogen. Reports of acquired carbapenemase-producing organisms in England more than doubled between 2021 and 2023, according to UK Health Security Agency (UKHSA) surveillance data.¹

Patients can carry CPE without symptoms while still transmitting it, and undetected spread inside hospitals can lead to outbreaks, longer stays and higher mortality. Infectious outbreaks, particularly those involving CPE, carry significant financial consequences for NHS hospitals through ward and theatre closures and disruption to elective care. Rapid diagnostics are central to reducing both the likelihood and impact of CPE spread.

The research is led by Dr. Jonathan Otter, Director of Infection Prevention and Control at Guy's and St Thomas' NHS Foundation Trust and Principal Investigator for the TRACE-CPE study, and Dr. Damien Ming, a research fellow at the Fleming Initiative and an honorary consultant in infectious diseases at Imperial College Healthcare NHS Trust.

"Antimicrobial resistance will not be addressed effectively by awareness alone. It will be solved by evidence, translated into practice, in the places where antibiotic decisions are actually made," said Dr. Jonathan Otter. "TRACE-CPE is the sort of cross-disciplinary collaboration the Fleming Initiative was created to enable. Our aim is a future where CPE does not spread in our hospitals, and rapid, accurate testing is central to making that future real."

The study compares rapid molecular CPE diagnostics, which can return a result in approximately one hour, against current culture-based screening, which typically takes around 48 hours. The TRACE-CPE study will:

• Test rapid CPE diagnostics in real-world NHS hospital settings to see how faster results affect clinical practice, infection control and hospital transmission.
• Study patient risk factors and colonisation patterns to understand how CPE spreads within hospitals.
• Assess costs, patient experience and system-level impact to determine the value and feasibility of implementing rapid screening at scale.

Conducted at Imperial College Healthcare NHS Trust and Guy's and St Thomas' NHS Foundation Trust, TRACE-CPE will run over two and a half years and draw on patient populations representative of the complexity and scale of acute care delivered by the NHS — providing a robust evidence base on how rapid molecular screening operates within frontline clinical workflows.

"Through our partnership with the Fleming Initiative, we are focused on generating the kind of evidence that determines whether diagnostics actually change outcomes inside the systems delivering care," said Anne Beaubrun, Vice President, Value and Access at Cepheid. "TRACE-CPE extends beyond diagnostic performance to assess how rapid screening influences health system productivity, transmission dynamics, and patient outcomes. It evaluates how these tools integrate into clinical workflows and infection prevention practices, generating evidence to strengthen antimicrobial stewardship (AMS), support delivery of the National Action Plan (NAP), and support evidence-based, long-term policy development in accordance with the NHS 10-year plan."

Findings from TRACE-CPE are intended to provide policymakers, hospital leaders and clinicians with the evidence base needed to determine how rapid CPE screening should be deployed across the NHS and comparable health systems facing the rising threat of drug-resistant infections.

References: 
1. UK Health Security Agency. Acquired carbapenemase-producing Gram-negative bacteria in England: October 2020 to September 2023. February 15, 2024. Accessed May 2025.
2. World Health Organization. Antimicrobial resistance. November 21, 2023. Accessed May 2025.

About Antimicrobial Resistance (AMR)
AMR occurs when microbes including bacteria, viruses, fungi and parasites change over time and no longer respond to the drugs and treatments society relies on to kill them and prevent disease. If measures are not urgently implemented to combat AMR, the consequences will be far reaching. Uncomplicated infections and minor injuries could once again become life-threatening.

AMR kills over 1 million people around the world each year² and is a growing challenge in treating leading infectious disease killers such as tuberculosis, Escherichia coli (E. coli), and Methicillin-resistant Staphylococcus aureus (MRSA). It has been caused in part by the widespread misuse and overuse of antibiotics and other antimicrobial medicines, in humans and livestock, which has led to the global spread of drug-resistant microbes. To effectively tackle AMR, global awareness and behavior change is needed.

About the Fleming Initiative
The Fleming Initiative is a global collaboration led through a partnership between Imperial College London and Imperial College Healthcare NHS Trust, committed to keeping antimicrobials working for the next 100 years. It combines science, policy and public engagement to create sustainable solutions to drug resistance through innovation, education and partnership. Read more at https://www.fleminginitiative.org/.

The Fleming Initiative is supported by the UK government, as highlighted in the 10 Year Health Plan for England, and receives funding from industrial partners including GSK, LifeArc and Cepheid. The Initiative is working to deliver solutions ranging from novel diagnostic tests, AI-based drug discovery to public health campaigns, to help mitigate the burden of resistant infections both domestically and further afield.

About Cepheid
Cepheid, a Danaher company and a global leader in molecular diagnostics, is dedicated to improving healthcare by pioneering molecular diagnostics that combine speed, accuracy, and flexibility. The company's GeneXpert® systems and Xpert® tests automate highly complex and time-consuming manual procedures, providing A Better Way for institutions of any size to perform world-class PCR testing. Cepheid's broad test portfolio spans respiratory infections, blood virology, women's and sexual health, TB and emerging infectious diseases, healthcare-associated and other infectious diseases, oncology, and human genetics. The company's solutions deliver actionable results where they are needed most—from central laboratories and hospitals to near-patient settings. For more information, visit https://www.cepheid.com.

Cepheid is proud to be part of Danaher. Visit www.Danaher.com to learn more about Danaher, a leading life sciences and diagnostics innovator committed to accelerating the power of science and technology to improve human health.

About Imperial College Healthcare NHS Trust
Imperial College Healthcare NHS Trust provides acute and specialist healthcare to over 1.5 million people a year. We are one of the largest NHS trusts in the country, with over 16,000 staff. Our five hospitals in central and west London – Charing Cross, Hammersmith, Queen Charlotte's & Chelsea, St Mary's and the Western Eye – have a long track record in research and education, influencing care and treatment nationally and worldwide. We also provide care remotely and from an increasing number of community facilities. We offer private healthcare in dedicated facilities on all our sites, too.
www.imperial.nhs.uk

Media Contact
Emma Yang
Supreme Communications
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Mikayla Hu
Fleming Initiative
[email protected]

SOURCE Cepheid