Oxford Immunotec launches revolutionary T SPOT-TB blood test

12th August 2004. At a time when the World Health Organisation has declared tuberculosis a global emergency, a revolutionary new blood test, T SPOT-TB, has been approved for use in Europe and gives real hope that the tide can be turned in the fight against the disease. 

Oxford Immunotec's new test is set to replace the century old tuberculin skin test, the oldest diagnostic test still in use today. The launch of T SPOT-TB is a key milestone in mankind's fight against this ancient disease and will bring TB care out of the Victorian era and into the 21st century.

T SPOT-TB enables doctors to reliably screen people who have been in contact with a TB sufferer, allowing those who have been infected to be identified and treated long before they actually develop the disease and become infectious to others.1,2 It provides an accurate and effective tool for controlling the spread of TB.3 

The T SPOT-TB blood test is easy, rapid and accurate. Crucially, it is the first test that reliably detects infection in people with weak immune systems,4 including new-born babies,5 people with HIV6 and transplant patients, precisely the people who are most vulnerable to developing full-blown TB. 

T SPOT-TB represents a dramatic improvement on the existing skin test, which is crude and unreliable. The skin test is prone to both false-positive and false-negative results and previous BCG vaccination makes it inconsistent. It is also inconvenient, taking 3 to 7 days before it can be read, and it can cause painful blistering and scarring of the skin.

Welcoming this exciting development, Paul Sommerfeld, Chair of TB Alert said, "The importance of having access to accurate and reliable diagnosis cannot be overstated. Accurate testing is vital for effective disease control, especially with the threat of multi-drug resistant TB and the recent increase in incidence of the disease hanging over us."

"The tools we use to diagnose TB are 50-100 years old; this disease has been neglected for decades. I am pleased that we have finally brought the benefits of modern scientific research to the front-line to fight this age-old disease", commented Dr Ajit Lalvani of Oxford University, the scientist who has led the development of the test over the last 10 years." In contrast to the crude and inaccurate skin test, the new blood test is fast, accurate and convenient. It is a 100-year upgrade for diagnosing TB and I believe it will significantly improve the way we manage tuberculosis." 

T SPOT(TM) works in a unique way. Whereas conventional diagnostic tests rely on detecting antibodies induced by an infection, such antibodies are not generated by TB infection. However, TB infection induces a strong response by immune cells in the blood called T-cells. It is these T-cells, in a small blood sample, that are detected by T SPOT-TB, which literally counts them as spots on a test plate. T SPOT-TB has already been proven in 16 clinical studies, involving over 4,000 people in 11 different countries. 

TB is currently out of control, causing three million deaths each year, more than any other infectious disease. In recent years, TB has resurged in Europe and, last week, the British Thoracic Society, British Lung Foundation and TB Alert highlighted the relentless increase in TB over the last 15 years in the UK.7 During this time, the number of TB cases in London has doubled and it is feared that the capital is on the brink of an epidemic. T SPOT-TB will enable more people to be diagnosed and treated while their infection is still dormant thus preventing them from developing full-blown tuberculosis which is highly contagious. T SPOT-TB is thus a powerful new tool to help health authorities curb and control the TB epidemic. 

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Media Enquiries:
Rebecca Todd 
Northbank Communications
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Tel: +44 (0) 20 7886 8150
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Email: r.todd@northbankcommunications.com  

At the Company:
Dr Peter Wrighton-Smith, CEO
Oxford Immunotec
91 Milton Park
Abingdon
Oxfordshire OX14 4RJ, UK

Tel: +44 (0)1235 442780
Fax: +44 (0)1235 442781
Email: info@oxfordimmunotec.com 

References
1. Lalvani A et al., Lancet 2001; 357: 2017-2021
2. Ewer K et al., Lancet 2003; 361: 1168-73
3. Lalvani A, Thorax 2003; 58: 916-8 
4. Richeldi L et al., Annals of Internal Medicine 2004; 140: 709-13 5. Richeldi L et al., American Journal of Respiratory and Critical Care Medicine 2004; 170:288-95 6. Chapman ALN et al., AIDS 2002; 16: 2285-2293 7. See press release available at www.brit-thoracic.org.uk 

Notes to editors
Oxford Immunotec:
Oxford Immunotec is a rapidly growing international clinical diagnostics company with headquarters near Oxford, UK. The Company develops and sells clinical diagnostic products based on its patented T SPOT(TM) technology. T SPOT is a novel platform technology that opens up new ways of diagnosing and monitoring infections by providing a simple and extremely accurate method of studying a person's cellular immune response to an infection. T-SPOT technology can be applied to diagnose and monitor any major disease driven by a T-cell response. Oxford Immunotec's first product is T SPOT-TB, a revolutionary new in vitro diagnostic test for tuberculosis infection, recently approved for sale in Europe. For more information, see www.oxfordimmunotec.com.

T SPOT-TB:
T SPOT-TB is a revolutionary new in vitro diagnostic test for tuberculosis infection. It is designed to replace the tuberculin skin test, currently the only test available for the diagnosis of TB infection. T SPOT-TB allows the reliable screening and early detection of TB infection and will bring TB testing to many new patient groups where the skin test gives poor or un-interpretable results. It offers a substantially more accurate and effective tool for controlling the spread of TB. 

The test works by detecting the presence of T cells in the blood that are specific to tuberculosis. T cells are the immune cells that the body produces when fighting TB infection. T SPOT allows the number of cells in the sample that have reacted to the infection to be counted, allowing the frequency of reacting cells circulating in the bloodstream to be estimated and the level of infection to be assessed.

The T SPOT-TB test has been tested in 16 clinical studies, involving over 4,000 patients in 11 different countries, in both the developed and developing world. 99.9% specificity was shown in healthy unexposed controls, in five separate studies of low-risk subjects. Sensitivity of the test has been shown to be over 96%.

About TB Alert:
TB Alert is a young charity, registered in late 1998 and launched at the Houses of Parliament on World TB Day (24th March) 1999. It was set up by people who felt that with its long tradition of TB work, there should be a greater response in Britain to the resurgent threat of tuberculosis - already declared a global emergency by the World Health Organisation
(WHO) in 1993. TB Alert is the first TB-specific charity in Britain since the 1960s when earlier organisations, assuming too soon that the disease had been vanquished, faded away or moved on to other interests. 

TB Alert aims to:
. Raise awareness of TB as a global threat and as a disease resurgent in Britain . Advocate for greater global spending on TB . Support TB control programmes overseas, focusing on increasing access to treatment especially for poor and marginalised groups . Complement the work of the NHS in the UK, supporting public and patient education and information

About tuberculosis: 
More people are dying of tuberculosis in the world today than at any other time in history. Over the last decades there has been a resurgence of TB in both the developed and developing world. It is thought that nearly a third of the world's population is infected by the tuberculosis bacteria and an estimated 8 million people develop the active disease every year.

TB is passed from person to person through the air, but a person exposed to TB does not necessarily go on to develop the disease. Some people are able to clear it from the system through their natural immune response, but most only control it and do not clear it completely, leaving it to remain dormant or "latent". This latent infection can reactivate at any time, causing the active disease.

TB is usually curable with effective antibiotic treatment. Typically a long course of a combination of four antibiotics is recommended for initial treatment of the active disease. If caught in its latent state, only one drug is usually needed to manage the disease. Due to poor compliance to therapy over the long period required to completely cure TB and because there have been few new drugs to treat TB over the last 30 years, there has been a substantial increase in the number of strains of TB resistant to current treatments. The rise and spread of multi-drug resistant (MDR) TB is a cause of great concern.