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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.
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.
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.
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.
Novel bioluminescent bacterial biosensors developed at UWE, Bristol, and commercialised by Randox, have been used by a range of companies to demonstrate effectiveness of drugs and decontamination procedures. This has improved development processes at companies including Clavis Pharma, Purest Solutions and Dycem, leading to new manufacturing processes and quality control test methods. The biosensors are used in novel applications to give pharmacodynamic data on effectiveness of drugs and real time in-situ demonstration of effectiveness of decontamination processes. These biosensors, pioneered and developed by Vyv Salisbury's group, have been commercially adopted and used for evaluation by at least six collaborating companies.
For stroke patients and any patient undergoing surgery the time period from diagnosis to treatment is a major factor in clinical outcomes. Research carried out at the University of Warwick has led to the development of sensors that can be used to measure, in whole unprocessed blood, diagnostically useful analytes that can be used to select the best therapeutic treatments. Point-of- care diagnosis and prompt referral to an appropriate care pathway, facilitated by the use of biosensors, will result in efficiency savings for healthcare professionals and the NHS in the long- term, and will also improve patient outcomes. To commercialize these biosensors, Sarissa Biomedical Ltd was founded in 2002, as a UK-based spinout from the University of Warwick. Sarissa sells, around the world, microelectrode biosensors fabricated by a unique enzyme deposition technology protected by patents filed in 2004 and 2008 by the University of Warwick. The diagnostic sensors are based on technology that incorporates Ruthenium Purple and use a sol-gel coating to entrap enzymes on a microelectrode. Sarissa is pursuing human trials of its biosensors as diagnostic tools in two main areas: stroke, and trauma with associated sepsis.
Research co-led by Prof Roz Anderson, in collaboration with a multi-disciplinary team, resulted in a new chromogenic substrate for the rapid detection and specific identification of the bacterial pathogen, Pseudomonas aeruginosa, a `super-bug' that threatens many thousands of hospital patients annually, leading to poor clinical outcome and increased risk of mortality.
bioMérieux adopted the technology for a new product, ChromID® P. aeruginosa, for commercial realisation as a clinical microbiology test; it was launched in the EU, USA and Australia, supporting the company's commercial position as leaders in this field. This test has enhanced the care of patients, through more rapid detection of P. aeruginosa and earlier informed clinical decision- making.
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.
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.