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Pioneering new immunoassays for inhibin A and B, developed by Professor Nigel Groome at Oxford Brookes University, have contributed to a significant improvement in the accuracy of pre- natal screening for Downs Syndrome. Use of inhibin A in the `Quad' and `integrated' tests, protected by international patents, is widespread in the US (c.3million screened annually) and was recommended by the NHS in 2010, leading to a significant increase in the use of the assays (c.120,000 annually) in the UK. They are also used in clinical diagnostic and monitoring applications for male and female infertility, abnormalities in sexual development in children and ovarian granulosa tumours. Commercialisation has led to royalty income to Brookes from sales which totalled approximately c.£5million in the period January 2008 to December 2012, indicative of the c.US$135million earned in worldwide sales in the same period.
This research significantly improved the accuracy of antenatal screening for Down's syndrome and the extent to which maternal choices are informed by robust evidence. Tests developed by Professor Nick Wald's team at Queen Mary's Wolfson Institute of Preventive Medicine and validated in the SURUSS (Serum Urine and Ultrasound Screening Study) study were adopted as national UK policy in 2003 and remain an established gold standard worldwide. As a result, most Down's syndrome babies in UK are now born through parental informed choice, and (using age-adjusted figures) approximately 3,000 fewer babies with the syndrome were born between 2008 and 2013. Screening programmes in numerous countries are based on this research.
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.
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.
Measurement of hormones is essential to the understanding and diagnosis of endocrine diseases. White and her research group have developed unique antibodies that are widely used in diagnostic assays for adrenocorticotrophic hormone (ACTH) and related peptides, including the first and only kit for measuring pro-opiomelanocortin (POMC), the precursor of ACTH. These assays are used worldwide for diagnosis, decisions on treatment, monitoring for recurrence of tumours and prognosis in a number of patient groups with life-threatening endocrine disorders. Global sales of the ACTH Elecsys tests by Roche exceeded 6 million kits since 2008. AstraZeneca has used the POMC and ACTH assays in its drug discovery programmes in the cardiovascular and metabolic diseases therapy area. The antibodies therefore have had health impact in relieving suffering and in improving patient care, as well as commercial impact in worldwide sales of assays and influencing drug development strategies.
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.
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.
University of Oxford researchers have developed the first safe, accurate and non-invasive prenatal diagnostic tests. After confirming that fragments of fetal DNA circulate in maternal blood, University of Oxford scientists used the polymerase chain reaction technique to accurately identify fetal DNA in maternal serum and plasma. This technique, known as cell-free fetal DNA testing, has enabled the first non-invasive prenatal genetic tests for the determination of fetal gender and the diagnosis of genetic disorders. Patented in 2001 and commercially released in 2011, cell-free fetal DNA testing is now recommended by the UK National Health Service as a safe and accurate alternative to invasive prenatal tests.