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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.
A research team, led by Professor John Robertson, was joined by Professor Herb Sewell as lead collaborator. They developed a blood test that permitted early detection of lung cancer in high risk patients, allowing earlier and more successful treatment. The EarlyCDT-Lung test was commercialised by the university spin-out, Oncimmune, and launched in 2010. It is in clinical use in North and South America, in private clinics in the UK and in some Middle East countries, generating employment and revenues for the company, and is starting to bring mortality and lifestyle benefits to patients and their families.
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 successful understanding and management of this infection have been profound.
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.
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.
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.
Researchers from St Georges have evaluated and optimised anti-fungal therapy for cryptococcal meningitis, the commonest cause of adult meningitis in sub-Saharan Africa. They have developed a "screen-and-treat" strategy to prevent the development of clinical disease in HIV-positive patients, and with collaborators developed and tested a novel point-of-care diagnostic test. These advances have led to changes in and development of a series of international guidelines and application of these new strategies in parts of Africa. A case for reduced costs of amphotericin was advanced by the group who were instrumental in reducing these costs in South Africa, allowing wider drug provision.
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.
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 for evaluation.
Pregnant women and public health service providers have benefitted since 2003 from the development of an ultra-sensitive immunoassay for inhibin-A — a hormone that is produced by the placenta during pregnancy and that is elevated in Down's syndrome pregnancies. The assay, developed by Professor Groome at Oxford Brookes University and Professor Knight at the University of Reading in 1994, was the first test capable of quantifying low levels of inhibin-A in the peripheral blood of humans. Addition of this test to existing antenatal screening tests improved the Down's syndrome detection rate from 59% to 70% and from 67% to 77% when combined with ultrasound imaging. Addition of inhibin-A as the fourth marker measured in the maternal blood serum became known as the quadruple or quad test and was adopted into UK clinical guidelines in 2003. It remains the recommended screening test for women who present themselves in the 2nd trimester. Since 2008 hundreds of thousands of UK women and their healthcare providers have benefitted from the additional information provided by this more accurate screening method, including whether more invasive diagnostic tests are wanted. The quadruple test has been widely adopted in the clinical guidelines in other countries including the US, Canada, and Australia.