It will be the first time the blood test has been used outside the US.
EarlyCDT-Lung, which has been available in America for two years, is a simple blood test which detects cancer at its earliest stages of development. This break-through in the diagnosis of lung cancer could save a significant number of lives as well as reduce the overall cost of care for this high risk population.
Funded by NHS Scotland, CEAC and Oncimmune Ltd, the randomised prospective trial is to ascertain the cost–effectiveness of EarlyCDT-Lung in screening high risk lung cancer patients. The trial will include 10,000 high-risk smokers. Screening will start before the end of 2012 and the first results are expected to be reported before the end of 2014.
Currently just nine per cent of lung cancer patients in the UK are still alive five years after diagnosis.
In the US EarlyCDT–Lung has been shown to detect early and late stage cancers in research studies as well as in clinical use.
The science behind the test
The blood test is based on pioneering research into the body’s immune response to cancer carried out over the last 15 years by Professor John Robertson who is Director of the Centre of Excellence for Autoimmunity in Cancer (CEAC) at The University of Nottingham and Chief Scientific Officer of Oncimmune Ltd.
Professor John Robertson said: “After many years of developing and refining this autoantibody test I am very proud of what we have achieved. The test is highly reproducible and will, I believe, lead to significant improvement in prognosis for a substantial number of lung cancer sufferers. The significant amount of performance validation work that we carried out before the test was launched in the US has led to the test performing commercially as expected. A randomised screening trial of this nature will help validate its use as a screening tool.
We are working hard on bringing the next test for the early detection of breast cancer to the market within a year. We are also working on a number of similar tests for prostate, colon and ovarian cancer — a blood test to aid detection of all tumour cancers (70 per cent of all cancer) is still the overriding objective of our work.”
How the screening will work
It can take months, even years for a cancer to develop — this process is known as carcinogenesis. During this period the immune system may recognise different proteins at different stages of the carcinogenesis process and make auto-antibodies to fight off the invader.
Half of the identified population in Scotland will have EarlyCDT-Lung; those who are positive will be followed up with low dose computed tomography (CT) scans in order to identify if lung cancer is present. The other half will not be screened with EarlyCDT-Lung but will have the current standard of care. The clinical outcomes and the overall cost of care including using the EarlyCDT–Lung test will be compared with the clinical outcomes and the overall cost of care of the non-screened group.
Sir Harry Burns, Chief Medical Officer for Scotland, said: “The earlier a cancer is diagnosed the greater the chance it can be treated successfully, and currently 85 per cent of patients with lung cancer remain undiagnosed until the disease has reached an advanced stage. This pilot project is part of our Detect Cancer Early programme, which aims to increase the early detection of cancer by 25 per cent. By testing those at greatest risk of developing lung cancer, and diagnosing it at its earliest possible stage, we stand a better chance of being able to treat the cancer successfully. This means patients can be treated when their general health is better and when less aggressive treatment may be required than if the cancer had spread.”
EarlyCDT–Lung will detect approximately half the cancers in the screened population and reduce the overall number to be followed up with CT to seven per cent. Having up to half the cancers in only seven per cent of the screened population should make the combination of EarlyCDT–Lung followed by CT highly cost effective. Initial calculations show that it may even reduce the overall cost of care for this high risk population whilst at the same time saving a significant number of lives.
Professor David Greenaway, Vice-Chancellor of The University of Nottingham, said: “This is excellent news. The ground-breaking research carried out by Professor Robertson and his team and the innovative techniques developed by Oncimmune have combined to produce a viable and cost effective blood test for cancer which has the potential to save many lives. This is truly translational research of which we can be proud. With the fund of knowledge and expertise brought together under CEAC hopefully it won’t be long before other cancers can also be identified at a stage where more lives can be saved. ”
Early detection is critical
Lung cancer is the world’s leading cause of cancer-related mortality and a major source of morbidity and mortality in the UK. Eighty five per cent of patients with lung cancer remain undiagnosed until the disease is symptomatic and has reached an advanced stage. Scotland has had one of the highest rates of lung cancer in the world. Survival across the UK is poor with less than nine per cent of patients still alive five years after diagnosis. This is due primarily to late stage of presentation.
Early detection of lung cancer and diagnosis improves prognosis — the current five-year survival rate is approximately 60 per cent for stage one lung cancer but only one per cent for those with stage four disease.
Geoffrey Hamilton-Fairley, Executive Chairman of Oncimmune Ltd, said: “It is very good news that a simple blood test with the potential to improve prognosis for lung cancer sufferers is now available. It is important that since the performance of the test has been proven clinically, we establish the test’s cost effectiveness which will enable broad adoption of EarlyCDT-Lung so that the benefits of early detection can become a reality.
The foresight of Scotland’s health team in identifying the clinical and economic benefits of a pre-screening test such as EarlyCDT-Lung and the speed with which they have put this trial in place is to be applauded.”
More about EarlyCDT–Lung
Oncimmune’s EarlyCDT-Lung test uses a panel of tumour antigens to detect the presence of immuno-biomarkers (autoantibodies) produced by the patient’s immune system when lung cancer is present. Elevation of any one of the panel of immuno-biomarkers (autoantibodies) above a predetermined cut-off value suggests that a tumour might be present. Previous studies have shown that immuno-biomarkers can be detected up to five years earlier than tumours can be seen in routine diagnostic imaging procedures. Tests that detect autoantibodies to a single tumour protein have been available for a number of years but have had low pick up rates (sensitivity). Previously, multiple antigen tests had low specificity, especially for early detection. Oncimmune’s EarlyCDT-Lung test has increased the sensitivity of the autoantibody test while maintaining a high level of specificity. The test is performed in Oncimmune’s CLIA-certified laboratory in Kansas City in the US.
The work of CEAC
Based on the early work of Professor Robertson, CEAC is leading research into the early detection and management of cancer and pushing forward the introduction of a blood test which can pick up the first signs of cancer as much as five years before some patients present with symptoms. Officially opened in January this year CEAC brings together a multi-disciplinary team of experts to lead to a better understanding of the molecular pathways that cancers in humans exploit as they develop and spread. This will help cancer specialists gain a greater insight into the associated immune response. The Centre is based at The University of Nottingham’s School of Graduate Entry Medicine and Health in Derby, England. Cancer: Early Detection is a flagship project within the University’s new appeal, Impact: The Nottingham campaign, aims to raise £150m to change lives, tackle global issues and shape the future.
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Notes to editors: The University of Nottingham, described by The Sunday Times University Guide 2011 as ‘the embodiment of the modern international university’, has 40,000 students at award-winning campuses in the United Kingdom, China and Malaysia. It is ranked in the UK’s Top 10 and the World’s Top 75 universities by the Shanghai Jiao Tong (SJTU) and the QS World University Rankings. It was named ‘the world’s greenest university’ in the UI GreenMetric World University Ranking 2011.
More than 90 per cent of research at The University of Nottingham is of international quality, according to the most recent Research Assessment Exercise. The University’s vision is to be recognised around the world for its signature contributions, especially in global food security, energy & sustainability, and health. The University won a Queen’s Anniversary Prize for Higher and Further Education in 2011, for its research into global food security.
More information is available from Lindsay Brooke, Media Relations Manager at The University of Nottingham on +44 (0)115 951 5751.
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