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Malaria is endemic in more than 100 countries but its rapid and accurate diagnosis in locations remote from clinical laboratory facilities remains challenging yet desperately needed. This case study describes how scientific discoveries made in the field of digital data storage have been developed and applied to deliver a rapid, reliable and low cost malaria diagnosis sensor suitable for field application. Diagnostic devices have been both laboratory-tested and clinically trialled on over 900 patients under adverse field conditions in malaria endemic countries with very promising results. The health impact includes not only significantly reducing unnecessary treatments but potentially saving millions of lives.
Research conducted by Professor Jo Bradwell at the University of Birmingham provided the basis of the commercially available diagnostic test Freelite®, which quantifies free immunoglobulin light chains in serum and was the first and only assay for the diagnosis and monitoring of Multiple Myeloma (MM). MM is a cancer of immunoglobulin producing plasma cells in the bone marrow. Freelite® has markedly improved the diagnosis and management of MM, is helpful in the diagnosis of all B cell lymphoid neoplasias and provides prognostic information for premalignant conditions present in over 3% of people over 50 years of age. Freelite was commercialised by the University of Birmingham spinout company, the Binding Site, which has achieved worldwide sales, with over 360,000 tests being sold per month in 90 countries and an ongoing 25% annual growth in sales. The company provides annual revenue of £55m and employment for 620 people in the UK and abroad. An improved second generation of tests has been developed by Professor Mark Drayson at the University of Birmingham, which has been commercialised by a second University spinout company Serascience, which started marketing a point of care free light chain diagnostic test worldwide in April 2013.
Impact: Changed public health policy by quantifying the level of asymptomatic vCJD infection in the population and the mechanism of its transmission, and by identifying cases of human-human transmission of vCJD via blood products.
Significance: UoE work informed the public and policy-makers of the risk of vCJD transmission, which resulted in policy changes and the implementation of precautions to prevent vCJD transmission and to limit the chance of a self-sustaining blood- or tissue-contamination-related secondary epidemic.
Beneficiaries: Patients, the NHS and healthcare delivery organisations, government, policy-makers.
Attribution: The work was carried out at UoE in the National Creutzfeldt-Jakob Disease Research and Surveillance Unit (NCJDRSU) and the Roslin Institute UoE (Roslin) with UK collaborators.
Reach: International, particularly UK and North America.
Meningococcal meningitis is a life-threatening acute disease affecting 1.2 million people every year. Accurate and rapid diagnosis is essential for optimal patient response; however, bacterial culture tests are slow and undermined by the immediate administration of antibiotics, resulting in sterile cultures.
The Surrey team developed a rapid, non-culture-based diagnostic test for meningitis and septicaemia: this test is now routinely used for diagnosis of meningococcal disease worldwide, and was also instrumental in the implementation and monitoring of control measures for the disease, such as life-saving vaccination campaigns. Together these have contributed to the halving of adult mortality rates from meningitis worldwide.
A long programme of research By Neil Avent has led to the development of powerful screening and diagnostic measures. It has enabled the implementation of molecular blood grouping and Non- invasive prenatal diagnosis (NIPD) into clinical use. The work began with research that took the lead in developing the commercially available products BLOODchip and MLPA, used extensively in the management of difficult to transfuse patients. This was developed into investigations of NIPD of fetal blood groups (particularly RhD), and through EC funding, drove workshops to establish non-invasive RhD typing as routine in the clinical management of haemolytic disease of the fetus and newborn. This work has shaped the standardisation of NIPT for fetal Rhesus D (RhD) and fetal sexing via External Quality Assessment (EQA) and the EC network Eurogentest.
Impact: altered business practice / new business venture created
Research into biophysical detection methods undertaken within PHYESTA has resulted in a Gothenburg-based multi-national, Mölnlycke Health Care, establishing a Scottish subsidiary (MHC Scotland) to exploit a commercial (exclusive license) partnership involving PHYESTA and Scottish Enterprise. This represents (i) creation of a new business sector for the company, and (ii) adoption of a new technology into its portfolio.
Significance: Mölnlycke Health Care has used its access to PHYESTA's IP portfolio, via license arrangements, as the primary vehicle for creating a new business venture enabling its entry into the diagnostics market for the first time.
Reach: Mölnlycke Health Care is a leading innovator in infection control in hospitals with employees in 30 countries worldwide. Its entry into the diagnostics market has implications for the entire company.
Beneficiaries: Impact in 2011-2013 pertains primarily to Mölnlycke Health Care and to the Scottish economy.
Attribution: This work was led by Professor Jason Crain, in collaboration with Professor Andrew Mount (Chemistry), Professor Peter Ghazal (Medicine), and Professor Anthony Walton (Engineering).
Meningococcal disease (MCD) is a major cause of morbidity and mortality worldwide. Underpinning research by Dr Carrol and colleagues at the University of Liverpool (1997-1999), has led to improved diagnosis and case confirmation, establishing Polymerase Chain Reaction (PCR) of meningococcal DNA as a gold standard test for diagnosis. The result is better management and therefore, impact on health and welfare of patients, and on practitioners. The work was conducted in collaboration with the Meningococcal Reference Unit, which provides a national diagnosis and surveillance service. The test was recommended in NICE guidelines in 2010, thereby impacting public policy.
Impact: Health and welfare; policy in the form of national and international guidelines; diagnostic service; engagement with patient groups.
Significance: UoE-formulated diagnostic criteria adopted by the World Health Organisation (WHO), the European Centre for Disease Prevention and Control (ECDC) and US Centers for Disease Control and Prevention (CDC), enable reliable case ascertainment and longitudinal study of disease trends. The UoE Creutzfeldt-Jacob Disease Unit acts as an international reference centre for diagnosis. Case ascertainment has improved.
Beneficiaries: Patients with prion disease and their families, policy-makers, the NHS, charities.
Attribution: The UoE CJD Unit led the work with international collaborators.
Reach: Worldwide; diagnostic criteria are WHO-endorsed and have been adopted worldwide. Pooling of data across Europe has enabled assessment of 11,000 cases of sporadic CJD.
Invasive pulmonary aspergillosis (IPA) is a frequently fatal disease of haematological malignancy patients, caused by fungi from the genus Aspergillus. Dr Christopher Thornton has developed and commercialised a novel point-of-care test for the diagnosis of IPA with an Aspergillus-specific monoclonal antibody (mAb) JF5 generated using hybridoma technology. Using this mAb, he has developed a lateral-flow device (LFD) for the rapid detection of Aspergillus antigen in human serum and bronchoalveolar lavage fluids (BALf) that signifies active infection. Commercial exploitation of the patented technology has been met through the establishment of a University of Exeter spin-out company, Isca Diagnostics Limited.
Research at the University of Liverpool (UoL) has developed and proven a straightforward diagnostic test method for bacterial blood infections. This was urgently needed as sepsis is a medical emergency that lacks adequate and rapid diagnostic tests particularly for low cost early detection. UoL's research has demonstrated that a simple optical test that can be conducted during routine testing of coagulation is an effective diagnostic, prognostic and monitoring marker for sepsis that can be routinely applied in clinical settings. There are now established UK and international laboratory standards in place. In 2010 a spinout company was formed to exploit four patents and incorporate the technology into a point-of-care device suitable for all clinical settings. The company, Sepsis Ltd, has attracted £1.45m of investment.