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Oxford Gene Technology Ltd. Marks World Lupus Day With Announcement of Novel Biomarker Panel to Support Earlier SLE Diagnosis


5/10/2013 9:36:42 AM

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Oxford, UK – 10 May 2013 – Oxford Gene Technology (OGT), provider of innovative genetics research and biomarker solutions to advance molecular medicine, has today announced the development of a novel autoantibody biomarker panel for improved diagnosis of systemic lupus erythematosus (SLE).

The panel has been developed in partnership with King’s College London, utilising OGT’s proprietary protein array platform technology. The platform detects autoantibodies, a class of proteins that have been shown to precede clinical symptoms of SLE by several years1. It also accurately distinguishes between SLE and ‘confounding diseases’ such as rheumatoid arthritis.

The biomarker panel, which was originally identified using a North American sample cohort, has been rigorously validated in two independent sample cohorts comprising over 450 European, Afro-Caribbean, and confounding disease samples. The panel maintains a high sensitivity and specificity across all cohorts studied.

SLE affects at least five million people worldwide, over 90% of whom are women. The figure may be higher as SLE is notoriously challenging to diagnose with widely variable symptoms which are inconsistent in patients. Current diagnosis is usually performed by comparing a patient’s symptoms against 11 pre-set criteria established by the American College of Rheumatology. If the patient presents any four of the symptoms simultaneously or serially on two separate occasions, they are classified as having SLE. Typically it takes several years and the involvement of many clinicians to diagnose an SLE patient.

Existing laboratory tests include antinuclear antibody (ANA) testing and anti-double stranded DNA (anti-dsDNA) testing but their specificity or sensitivity is too low to support the diagnosis or classification of SLE without additional data. The OGT panel would allow for earlier and more accurate diagnosis than existing tests addressing a clear unmet medical need.

Dr Mike Evans, CEO at OGT said, “SLE is a truly debilitating disease that is particularly challenging to diagnose. Our novel diagnostic biomarker panel is more sensitive and specific than existing laboratory tests and it is our hope that, by correctly identifying the presence of SLE at an earlier stage, patients will receive faster access to the most appropriate treatment. We are pleased with the progress of our biomarker portfolio, which also includes advanced programmes in prostate and colorectal cancer, and we are currently evaluating potential partners to develop diagnostic tests based on the SLE biomarkers.”

Professor Tim Vyse, Division of Genetics and Molecular Medicine at King’s College London said: “The OGT SLE panel represents a big step forward in lupus genetic testing and the outcome of the programme so far has been very encouraging.”

OGT is also in discussions with SLE drug developers regarding potential prognostic applications of the biomarkers set to predict the occurrence and frequency of relapse, or ‘flares’, so that treatment regimens can be adjusted accordingly and patient well-being maximised.

OGT and King’s will present the results of the programme at the European League Against Rheumatism (EULAR) Meeting from 12-15 June 2013 (www.eular.org).

References:

1. Arthritis & Rheumatism, Volume 56, Issue 7, July 2007, pp. 2344-235; Arbuckle NEJM 2005

About systemic lupus erythematosus (SLE)

Lupus is a systemic autoimmune disease that can affect any part of the body. As with other autoimmune diseases, the immune system attacks the body’s cells and tissue resulting in inflammation and tissue damage. The most common areas of damage are the heart, joints, skin, lungs, blood vessels, liver, kidneys and nervous system. The cause of the disease is difficult to identify but can be triggered by a viral infection, strong medication, trauma, sunlight and puberty, childbirth and menopause in women. Periods of illness known as flares alternate with remissions. There is no cure for SLE; it is treated with immunosuppression, mainly cyclophosphamide and corticosteroids. It is reported that between 10-15 per cent of people with lupus will die prematurely due to complications of lupus.

About Oxford Gene Technology

Founded by Professor Ed Southern, Oxford Gene Technology (OGT) provides innovative genetics research and biomarker solutions to advance molecular medicine. The Company has two trading businesses: Genomic Solutions comprises of CytoSure™ cytogenetics array, labelling and interpretation software products and services for the detection of chromosomal abnormalities, and Genefficiency™ Genomic Services, a unique combination of platforms, expertise and processing capabilities to deliver rapid, relevant genomic data. CytoSure and Genefficiency NGS browser: For research use only. Not for use in diagnostic procedures.

The Diagnostic Biomarkers business utilises proprietary next generation technologies to build a rich patent-protected portfolio of promising biomarkers for early stage cancer detection including advanced programmes in colorectal and prostate cancer plus the autoimmune disease systemic lupus erythematosus.

For more information on the Company, please visit our website at: www.ogt.com

King's College London

King's College London is one of the top 30 universities in the world (2011/12 QS World University Rankings), and the fourth oldest in England. A research-led university based in the heart of London, King's has more than 25,000 students (of whom more than 10,000 are graduate students) from nearly 140 countries, and some 6,500 employees. King's is in the second phase of a £1 billion redevelopment programme which is transforming its estate.

King's has an outstanding reputation for providing world-class teaching and cutting-edge research. In the 2008 Research Assessment Exercise for British universities, 23 departments were ranked in the top quartile of British universities; over half of our academic staff work in departments that are in the top 10 per cent in the UK in their field and can thus be classed as world leading. The College is in the top seven UK universities for research earnings and has an overall annual income of nearly £450 million.

King's has a particularly distinguished reputation in the humanities, law, the sciences (including a wide range of health areas such as psychiatry, medicine, nursing and dentistry) and social sciences including international affairs. It has played a major role in many of the advances that have shaped modern life, such as the discovery of the structure of DNA and research that led to the development of radio, television, mobile phones and radar. It is the largest centre for the education of healthcare professionals in Europe; no university has more Medical Research Council Centres.

King's College London and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts are part of King's Health Partners. King's Health Partners Academic Health Sciences Centre (AHSC) is a pioneering global collaboration between one of the world's leading research-led universities and three of London's most successful NHS Foundation Trusts, including leading teaching hospitals and comprehensive mental health services. For more information, visit: www.kingshealthpartners.org.

For more information, please contact:

Oxford Gene Technology

Stephen Archibald, Director of Communications

Oxford Gene Technology, Begbroke Science Park, Begbroke Hill, Woodstock Road, Begbroke, Oxfordshire, OX5 1PF

T: +44 (0) 1865 856826

F: +44 (0) 1865 848684

E: products@ogt.com

W: www.ogt.com

College Hill (PR Agency for Oxford Gene Technology)

Melanie Toyne Sewell / Jen Lewis

College Hill, The Registry, Royal Mint Court, London, EC3N 4QN

T: +44 (0) 20 7457 2029

E: OGT@collegehill.com



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