The test will be the first in a pipeline of affordable, portable, easy-to-use, graphene-based IVD products, which will at least match the performance of the most advanced hospital laboratory, but at the point of care.

Paragraf, the first company in the world to deliver a scalable approach to graphene electronic device manufacturing, announces a plan to develop a new generation of graphene-based, in-vitro diagnostic products that will give results within a few minutes.

The Cambridgeshire-based company is starting a two-year programme to develop a proof-of-concept combined PCT (procalcitonin) and CRP (C-reactive protein) test, on a single panel. This collaboration utilises a GBP £550,000 Biomedical Catalyst grant award from Innovate UK, the UK’s innovation agency.

Paragraf is collaborating with the Universities of Liverpool, Manchester and Newcastle, Newcastle upon Tyne Hospitals NHS Foundation Trust and Manchester University NHS Foundation Trust (MFT), on the development.

A clinical study of the combined PCT/CRP test will be delivered at MFT’s Diagnostics and Technology Accelerator (DiTA) in mid-2023. DiTA aims to address unmet needs, transform patient care and improve efficiency within the NHS, by facilitating the rapid translation and adoption of new innovations into the health and care system. The project is expected to be completed by the end of May 2024.

Paul Dark, Professor of Critical Care Medicine at The University of Manchester, and Honorary NHS Consultant at Salford Royal, part of Northern Care Alliance NHS Foundation Trust, stated: “Nobel laureate scientists at The University of Manchester first isolated graphene in 2004 and so our city can claim to be the birthplace of the graphene industry. Today we are proud to announce that we will be working with Paragraf to develop this proof-of-concept graphene-based diagnostic.”

Professor Dark also leads the National Institute for Health and Care Research (NIHR) Manchester Biomedical Research Centre (BRC), Respiratory Non-fungal Infections Programme, which is focused on providing more accurate, rapid diagnosis for patients with severe respiratory infections. He said: “We expect to show that our proposed acute inflammatory marker test will have the capability to deliver accurate results for emergency patient care within a few minutes, from a small sample of blood. The accuracy of the test is envisaged to be at least comparable with hospital centralised lab-based immunoassay (antibody) tests which can take hours to provide results back to emergency services.”

Dr Tim Felton, Director of DiTA and an Intensive Care Consultant at Wythenshawe Hospital, which is part of MFT, said: “The main benefit of a single PCT and CRP test, is that a combined test increases confidence in the accuracy of the result when discriminating between bacterial and other infections.”

Dr Felton, who is also a Manchester BRC Researcher, within the Respiratory theme, added: “An accurate test able to provide results that can guide antibiotic therapy in real time is becoming a critical tool in the fight against antibiotic resistance.”

Professor Enitan Carrol, Professor of Paediatric Infectious Diseases at the University of Liverpool, added: “This technology reduces the time and complexity of sample preparation which, together with its rapid measurement speed, provides clinicians with accurate results in a timeframe that allows immediate decisions to be made on antimicrobial prescribing. This is especially important for the treatment of children and neonates.”

Malcolm Stewart, Paragraf Diagnostics Business Development Director, said: “This graphene-based diagnostic test is expected to become the first test in the world to give clinicians the ability to identify patients who need an antibiotic treatment within the space of a regular 15-minute clinic appointment. It encourages antimicrobial stewardship by giving clinicians the insight into when not to prescribe antibiotics as the test result differentiates viral from bacterial infections.

Paragraf will go on to deliver a series of high sensitivity, rapid tests for disease biomarkers in areas including cardiovascular disease, oncology, and infectious diseases.

The ambition is to develop a comprehensive suite of tests that could be used in almost any environment or healthcare setting. Our tests are designed to provide ultra-fast answers to diagnostic challenges and to reach beyond the concept of point of care testing to create a complete diagnostic toolkit at the point of need.”

Dr Will Jones, Senior Clinical Test Methodologist at the National Institute for Health and Care Research (NIHR) Newcastle In Vitro Diagnostics Co-operative (MIC), who will oversee the interviews with stakeholders, said: “This exciting project provides the opportunity for clinicians, patients and the public to shape the development of a novel diagnostic test technology.”

Simon Thomas, Paragraf CEO, said: “Paragraf has the ambition and proven ability to become a deep-tech graphene pioneer across several industries and, with our disruptive pipeline in novel IVD products, we aim to make a major contribution to resolving some of the most intractable problems in healthcare globally, including antimicrobial resistance, the early detection of cancers, and cardiovascular diseases.

Paragraf is notable for its unique manufacturing process to reproducibly produce high purity, high-quality graphene directly on a substrate with minimal contamination. This proprietary process allows Paragraf to claim that it is the first company in the world to deliver a scalable approach to graphene-based electronic device manufacturing, with an unrivalled ability to harness one of the most conductive materials in the world.”

Paragraf raised USD $60 million in Series B financing announced on March 1, 2022.

About The NIHR Manchester Biomedical Research Centre (BRC)

The NIHR Manchester Biomedical Research Centre (BRC) is hosted by Manchester University NHS Foundation Trust and The University of Manchester, in partnership with Northern Care Alliance NHS Foundation Trust and The Christie NHS Foundation Trust.

The BRC’s vision is to drive health improvements and lasting change for all through creative, inclusive and proactive research that identifies and bridges gaps between new discoveries and individualised care.

Funded by the NIHR from 2017-2022, Manchester BRC provides world-leading research into:

• Biomarker Platforms
• Cancer
• Dermatology
• Informatics and Data Sciences
• Hearing Health
• Musculoskeletal Disease
• Respiratory Disease

About Manchester University NHS Foundation Trust (MFT)

Manchester University NHS Foundation Trust (MFT) is one of the largest NHS trusts in the country and a leading provider of specialist healthcare services. Its 10 hospitals are home to hundreds of world class clinicians and academic staff, committed to finding patients the best care and treatments. Its hospitals are Manchester Royal Infirmary, Saint Mary's Hospital, Royal Manchester Children's Hospital, Manchester Royal Eye Hospital, North Manchester General Hospital, University Dental Hospital of Manchester, Trafford General, Altrincham Hospital, Wythenshawe Hospital and Withington Hospital.

About the National Institute for Health and Care Research (NIHR)

The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:

• Funding high quality, timely research that benefits the NHS, public health and social care;
• Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
• Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
• Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
• Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
• Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.

NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.

About The University of Liverpool

Founded in 1881 as the original ‘red brick’, the University of Liverpool is one of the UK’s leading research-intensive higher education institutions with an annual income of £577.7 million, including £98.6 million for research.

Consistently ranked in the top 200 universities worldwide, the University of Liverpool is a member of the prestigious Russell Group of the UK’s leading research universities and has a global reach and influence that reflects its academic heritage as one of the country’s largest civic institutions.

The University of Liverpool has 33,500 students, 9,000 of whom travel from all over the world to study here, and a thriving community of 240,000 alumni in 191 countries.

About The University of Manchester

The University of Manchester, a member of the prestigious Russell Group, is one of the UK’s largest single-site universities with more than 40,000 students – including more than 10,000 from overseas. It is consistently ranked among the world’s elite for graduate employability. The University is also one of the country’s major research institutions, rated fifth in the UK in terms of ‘research power’. World-class research is carried out across a diverse range of fields including cancer, advanced materials, global inequalities, energy and industrial biotechnology.

About Newcastle University

Newcastle University, UK, is a thriving international community of some 27,750 students from over 130 countries worldwide. As a member of the Russell Group of research-intensive universities in the UK, Newcastle has a world-class reputation for research excellence in the fields of medicine, science and engineering, social sciences and the humanities.

Its academics are sharply focused on responding to the major challenges facing society today. Our research and teaching are world-leading in areas as diverse as health, culture, technology and the environment. Newcastle University is committed to providing our students with excellent, research-led teaching delivered by dedicated and passionate teachers. Newcastle University is ranked 122nd in the QS World Ranking 2023 and Joint 146th in the Times Higher Education World University Ranking 2022.

About Newcastle Hospitals NHS Foundation Trust

Newcastle Hospitals provides care to patients and their families, across communities in the North East of England and beyond, with over 1.8 million patient contacts every year. We are one of the largest NHS Trusts in the UK, offering a wide range of specialist services, in the community and across our hospital sites which include the Freeman Hospital, Royal Victoria Infirmary, Great North Children’s Hospital, Campus for Ageing and Vitality, Newcastle Dental Hospital and Newcastle Fertility Centre.

Rated ‘Outstanding’ by the Care Quality Commission (CQC) for the second consecutive time in 2019, we have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.

In June 2019, Newcastle Hospitals became the first healthcare organisation in the world to declare a climate emergency recognising that a climate emergency is a health emergency.

About Paragraf

Paragraf is the world’s leading technology development and manufacturing team for graphene-based electronic devices. Paragraf’s proprietary process commercially develops and delivers the highest quality graphene products which will revolutionise many critical applications with contamination-free technology.

Paragraf is the first company worldwide to provide scalable, high spec graphene electronic device manufacturing for the sensors and diagnostics markets.