Encouraging Early Results of Major 10,000 Patient National Health Service (NHS) Lung Cancer Screening Trial using EarlyCDT®-Lung Blood Test Announced at the 16th World Conference on Lung Cancer
- Encouraging early results - cancer pick up rate considerably better than stated test performance; positivity rate as expected
- The Study is the largest randomized trial for the early detection of lung cancer using biomarkers ever conducted
- Final results may enable the adoption of EarlyCDT-Lung screening by other countries
DENVER, Sept. 8, 2015 /PRNewswire/ -- Encouraging early results from the largest ever randomized trial for lung cancer using autoantibody biomarkers were announced at the International Association for the Study of Lung Cancer's 16th World Conference on Lung Cancer (WCLC). The initial results of the NHS Scotland-sponsored ECLS Study1 of 10,000 high-risk smokers were presented by Professor Frank Sullivan, FRSE, FRCP, FRCGP, CCFP, Abstract #48: "Progress with a randomized controlled trial of the detection in blood of autoantibodies to tumor antigens as a case-finding method in lung cancer using the EarlyCDT-Lung test in Scotland (ECLS)."
The ECLS Study uses the EarlyCDT-Lung blood test developed by Oncimmune, a leader in early cancer detection. The early results of the Study demonstrate the cancer detection rate (sensitivity) of 81%, which is considerably better than the test performance states at 41%. The positivity rate is as expected with a specificity of 91%. However, it should be noted that the control arm has not been formally assessed. The final data on the control arm will be collected at the end of the Study.
Professor Frank Sullivan, Chief Investigator of the ECLS Study, said, "ECLS has recruited nearly 10,000 patients to date and will complete the recruitment of an additional 2,000 patients in early 2016 with full results available after two years of follow-up. It has been a major effort to recruit such an impressive number of Study participants. Overall positivity rate for the test is as expected at 91%. Provisional encouraging data reporting the numbers of early cancers being detected in the test arm were presented at the World Conference on Lung Cancer."
First announced in March 2012, the Early Cancer Detection Test – Lung Cancer Scotland (ECLS) Study is designed to determine whether use of the EarlyCDT-Lung blood test leads to earlier detection of lung cancer and can help to save lives in the long term. The rationale is that patients pre-identified as being at high risk of lung cancer take the EarlyCDT-Lung blood test. Those who receive a positive result are effectively triaged into a much higher risk group and are referred for X-ray and low dose CT-Scan (Low Dose Computed Tomography). This high-risk selection protocol results in many fewer low dose CT-Scans but with the same, already established National Lung Screening Trial (NLST)2 mortality benefit of low dose CT-Scans.
"We are pleased by the initial results of this independent Study, which supports the wealth of data on the use of autoantibodies in cancer detection and are consistent with our previous EarlyCDT-Lung validation studies. If these results continue, it will further underpin the rationale of the ECLS Study – namely that screening with the EarlyCDT-Lung blood test can be effective for the early detection of lung cancer, helping to save lives and money. We look forward to ECLS reporting updates on an ongoing basis," said Geoffrey Hamilton-Fairley, CEO, Oncimmune Limited.
These are initial results only. Further interim results will be announced over the next three years with final publication expected in 2018-2019. These Study results will enable the NHS to make a decision about whether to offer the EarlyCDT-Lung blood test as a nationwide screening test in the future and may enable the adoption of EarlyCDT-Lung screening by other countries. Nearly 10,000 high-risk patients have already been enrolled into the ECLS Study. However recruitment will continue until a total of 12,000 patients have been enrolled to ensure robust statistically significant results are achieved in the shortest time possible.
About the ECLS Study
Lung cancer kills more people than any other cancer worldwide, with over 1.5 million deaths globally in 2012. In Scotland, nearly 5,000 people die from lung cancer every year.3
It is often hard to find lung cancer early. Most people with early lung cancer do not have any symptoms, so only a small number of lung cancers are found at an early stage when treatment can be most successful. It is for this reason that the Scottish Government is co-funding the Early Cancer Detection test – Lung Cancer Scotland (ECLS) Study along with Oncimmune Ltd, the company which developed EarlyCDT-Lung, the blood test being trialed in the Study. This EarlyCDT-Lung blood test may be able to pick up very small lung cancers before symptoms are evident.
The Study originally invited 10,000 high-risk people from Scotland's Tayside, Glasgow and the surrounding areas to participate. An additional 2,000 patients will now be recruited and some of these will come from Lanarkshire. These regions have been chosen because lung cancer is more common in these areas. Those who agree to participate in the ECLS Study either receive an EarlyCDT-Lung test or are followed up by usual care. Patients with a positive blood test are offered a chest X-ray and a series of CT scans over two years. All participants requiring further investigations or treatment are treated within NHS guidelines. For more information visit: http://www.eclsStudy.org/home
A key outcome of this Study will be the cost-effectiveness of screening high-risk patients with EarlyCDT-Lung. Although the first results will be published in 2018-2019, ECLS Study investigators want to find out if earlier detection saves lives in the long term by following everyone who takes part in the Study for up to 10 years. Patient feedback regarding EarlyCDT-Lung also will be sought as part of the NHS decision process to determine whether to offer the test as a nationwide lung cancer-screening test.
About EarlyCDT-Lung
EarlyCDT®-Lung is a simple blood test which is ordered by a physician to aid in the risk assessment and early detection of lung cancer in moderate and high risk patients, and to stratify indeterminate pulmonary nodules for the risk of malignancy. The test's overall accuracy is greater than 91%4.
When a tumor is present it produces abnormal proteins (known as antigens). Antigens from a person's own cells are not normally found in the body. The body reacts to these antigens by producing autoantibodies. The test measures a panel of seven autoantibodies to detect the presence of lung cancer.
EarlyCDT-Lung has been developed so that individuals at moderate or high risk of developing lung cancer can benefit from an increasing chance that lung cancer can be detected at the earliest possible stages, when treatment can be most successful. The EarlyCDT-Lung test can also be used in conjunction with diagnostic imaging such as X-ray or CT scan to further assess the risk of lung cancer being present where indeterminate lung nodules have been detected which may or may not be a sign of cancer.
About Oncimmune
Oncimmune is an industry leader in early cancer detection. The company has pioneered the development of autoantibody assay technologies that have the potential to allow earlier cancer detection than other methods and be applied to a very wide range of solid tumor types. The Company's proprietary EarlyCDT® technology platform was launched in 2009. EarlyCDT-Lung is currently available through physicians in the US and also privately in the UK and other regions. EarlyCDT® tests for liver and ovarian cancer are in final validation. Oncimmune is headquartered in Nottingham, United Kingdom with testing facilities in the US. For more information: www.oncimmune.com.
1 http://www.eclsStudy.org/
2 http://www.cancer.gov/types/lung/research/nlst-qa
3 Cancer Research UK (http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/lung-cancer/incidence). American Cancer Society (http://www.cancer.org/cancer/lungcancer-non-smallcell/detailedguide/non-small-cell-lung-cancer-key-statistics).
4 EarlyCDT®-Lung test: improved clinical utility through additional autoantibody assays. Chapman CJ, Healey GF, Murray A, Boyle P, Robertson C, Peek LJ, Allen J, Thorpe AJ, Hamilton-Fairley G, Parsy-Kowalska CB, Macdonald IK, Robertson JFR. Tumor Biol. 201;33 (5):1319-26. doi: 10.1007/s13277-012-0379-2
SOURCE Oncimmune
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