Association for the Study of Lung Cancer's 16th World Conference on Lung Cancer ("WCLC").
The National Health Service ("NHS") Scotland-sponsored Early Cancer Detection Test – Lung Cancer Scotland ("ECLS") Study of 10,000 high-risk smokers demonstrated a cancer detection rate (sensitivity) of 81% for EarlyCDT®-Lung in these initial results. While the control arm in the study has not been formally assessed, the positivity rate was as expected with a specificity of 91%. The final data on the control arm will be collected at the end of the study.
EarlyCDT®-Lung is a blood test, easily done, that aids physicians in risk assessment and the early detection of lung cancer in high-risk, asymptomatic patients. GeneNews' Innovative Diagnostics Laboratory LLP ("IDL") joint-venture is licensed to distribute and perform the EarlyCDT®-Lung test in the United States. The test is reimbursed by both Medicare and commercial insurers.
First announced in March 2012, the ECLS Study was established to determine if the use of EarlyCDT®-Lung leads to earlier detection of lung cancer and can help to save lives in the long term. As part of the study, half of the patients pre-identified as high-risk for lung cancer were followed up by usual care, and half were asked to take the EarlyCDT®-Lung test. Those who received a positive result were effectively triaged into a much higher risk group and referred for X-ray and low dose computerized tomography (CT) scans. This higher-risk selection protocol results in many fewer low dose CT scans, but with the same mortality benefit of low dose CT scans already established in the U.S. National Lung Screening Trial ("NLST").
"Lung cancer is usually detected only in its late stages when symptoms are evident, treatment more complicated, and survival lower," said James Howard-Tripp, Executive Chairman, GeneNews. "This is why the adoption of EarlyCDT®-Lung as an indicator of early lung cancer is so important. It is an aid to physicians in assessing high-risk patients and then stratifying those with a positive finding to increased testing, with the objective of finding the disease early and treating it early. This is the message we can take to the physicians, patients and insurers with greater clarity now."
"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," explained Professor Frank Sullivan, Chief Investigator of the ECLS Study, who presented the trial results at WCLC. "It has been a major effort to recruit such an impressive number of study participants."
Further interim results from the study will be announced over the next three years with final publication of the study anticipated in 2018-2019. Once concluded, the trial will enable the NHS to determine whether to offer the EarlyCDT®-Lung blood test as a nationwide screening in the future, and may enable the adoption of the testing by other countries.
About the ECLS Study
Lung cancer kills more people than any other cancer worldwide, with over 1.5 million deaths globally in 2012. In the United States, more than 155,000 people die from lung cancer every year.
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 ECLS Study along with Oncimmune Ltd, the company who developed EarlyCDT®-Lung, the autoantibody biomarker 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 the test should be offered as a nationwide lung cancer-screening test.
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%.
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 scans 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.
GeneNews is focused on developing and commercializing proprietary molecular diagnostic tests for the early detection of diseases and personalized health management, with a primary focus on cancer-related indications. The Company's lead product, ColonSentry®, is the world's first blood test to assess an individual's current risk for colorectal cancer. In 2013, GeneNews created a U.S. joint venture, Innovative Diagnostic Laboratory, LLP ("IDL"), that it is committed to help become a leader in molecular diagnostics and personalized medicine, serving as a strong commercialization outlet for advanced cancer tests. Taking a multi-view approach to the diagnosis and treatment of cancer, IDL is working to assemble, through a combination of internal pipeline development, third-party licenses and potential acquisitions, a robust menu of novel, proprietary tests to be offered by it throughout the United States. GeneNews' common shares trade on the Toronto Stock Exchange under the symbol 'GEN'. More information on GeneNews and IDL can be found at www.GeneNews.com and www.MyInnovativeLab.com, respectively.
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