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Kidney disease affects about 10% of the population and 10% of these patients develop established kidney failure (ERF). Transplantation is a better treatment for ERF than dialysis but is limited by acute and chronic graft rejection. Treatment of rejection mediated by the recipient's T-lymphocytes is now remarkably successful, but antibody-mediated rejection (AMR) remains challenging. A principal cause of AMR is recipient antibodies targeting human leukocyte antigen (HLA, also known a tissue type) on the transplant organ. The presence of such antibodies previously vetoed transplantation but in the last ten years it has become increasingly feasible to transplant across HLA antibody barriers. Research at the University of Warwick (UoW) by Dr Daniel Zehnder and Professor Robert Higgins has facilitated and accelerated this process. Their research includes the first detailed monitoring of antibody levels after transplantation, showing how these affect graft function, and the development of new techniques to remove antibodies from patients. This resulted in over 100 HLA-mismatched renal transplants taking place in Coventry giving a net saving to the NHS of over £5M. Their research and its clinical translation encouraged the performing of another 350 such transplants across the UK and initiation of the National Case Registry.
Annually in the UK ~110,000 donor platelet concentrates are used to prevent bleeding in cancer patients and ~660 newborns are born with an increased risk of bleeding because of a low platelet count caused by maternal platelet antibodies. These newborns and ~10% of the cancer patients require donor platelet transfusions matched for the platelet antibody because non-matched donor platelets are clinically less effective. University researchers have developed better methods for platelet antibody detection and typing and as a direct consequence of this research NHS Blood and Transplant (NHSBT) has from 2009 onwards been able to make platelet transfusions safer and clinically more effective, thereby reducing the number of severe, and on occasions life- threatening, bleeding episodes.
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.
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.
BioAnaLab's mission is to advance innovative biopharmaceuticals, such as therapeutic antibodies for cancer treatment, into the clinic. From 1995, the University of Oxford pioneered methodology essential for validating top quality therapeutic antibodies and monitoring their activity in patients. This expertise led to the establishment in 2002 of BioAnaLab, a successful Isis Innovation spin-out company. By 2009 BioAnaLab employed 50 staff providing analytical services to approximately 100 pharmaceutical and biotechnology companies worldwide and had annual sales exceeding £3.13 million. BioAnaLab was subsequently acquired in 2009 by Millipore Corporation to become an integral part of Merck/Millipore's global drug discovery unit.
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.
The production and use of monoclonal antibody, ALK1, by researchers in Oxford has been pivotal in enabling the accurate diagnosis and treatment of Anaplastic Large Cell Lymphoma (ALCL). This research also led to the formal classification of ALK-positive ALCL tumours by the World Health Organization in 2008. While ALCL accounts for 10-20% of paediatric/adolescent non-Hodgkin's lymphoma worldwide, its diagnosis had been problematical due to the absence of suitable reagents. This was remedied in 1997 when Oxford researchers created the first monoclonal antibody, ALK1, recognising anaplastic lymphoma kinase (ALK), a molecule that is associated with up to 90% of ALCL.
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.
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.
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.