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.
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
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
company Serascience, which started marketing a point of care free light
chain diagnostic test
worldwide in April 2013.
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.
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
Chronic lung infections due to Pseudomonas aeruginosa are the major cause of morbidity and
mortality associated with cystic fibrosis. Some strains of P. aeruginosa transmit between patients
(epidemic strains). The Winstanley group, at the University of Liverpool (UoL) since 1999, in
collaboration with clinicians in Liverpool, has developed diagnostic PCR assays for identification of
the most widely reported UK epidemic strains of P. aeruginosa. The NHS clinicians use these
tests to make informed decisions about patient segregation leading to markedly reduced incidence
of LES infections. Researchers internationally have adopted the UoL research results and strategy
to tackle other transmissible strains and modify clinical procedures.
The MRC Prion Unit was established at UCL in 1998 to address national
public health issues posed by bovine spongiform encephalopathy (BSE) and
variant Creutzfeldt-Jakob disease (vCJD). One of our key strategic
priorities has been to create a validated blood test for vCJD in order to
protect public health through the screening of donated blood and organs
for transplantation. The blood test we have developed has been
demonstrated to detect infection in over 70% of patients with vCJD with,
to date, 100% specificity and is now in use at the National Prion Clinic
Impact: Health and welfare; policy in the form of national and
international guidelines; diagnostic service; engagement with patient
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
Beneficiaries: Patients with prion disease and their families,
policy-makers, the NHS, charities.
Attribution: The UoE CJD Unit led the work with international
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.
Clostridium difficile infection (CDI) is a frequent and often
fatal hospital-acquired infection. In the
past, the diagnosis of CDI has been inadequate. This has had serious
consequences for the
management and control of infection in healthcare settings. Planche and
colleagues at St
George's have developed and validated a new diagnostic algorithm for CDI.
This has led to policy
changes in the UK Department of Health, and amongst European and US
authorities, and to
practical changes in the way CDI is diagnosed. Its implications for the
and management of this infection have been profound.
Since its discovery in the 1980s, avian metapneumovirus (AMPV) has spread
in poultry populations worldwide with major adverse health and food
security implications for commercial chickens and turkeys. Research at the
University of Liverpool (UoL) led to the registration of a live vaccine in
1994 which has played a global role in AMPV control, thereby safeguarding
the supply of poultry meat and eggs. Recent research and development at
the UoL has identified key control measures, relating to vaccine
application, vaccine selection, efficacy and safety, which have had a
significant impact on poultry health and consequently, poultry producers
and consumers. In particular, demonstration that live AMPV vaccines can
revert to virulence, that vaccine type applied influences field protection
and that continuous use of a single vaccine can influence circulating
field strains, has resulted in UoL leading policy making with regard to
current AMPV vaccine protocols.
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.