About the Study

This current publication reports on three separate cohorts, totaling 655 patients with newly-diagnosed lung cancer. All patients with lung cancer were individually matched by gender, age, and smoking history to a control individual (high-risk normal) with no previous history of cancer. Patients were from the United States, Russia, Germany, United Kingdom, and the Ukraine. Samples were run in a blinded fashion in Oncimmune's CLIA-certified laboratory in the metro Kansas City area. "The publication reports the clinical validation of EarlyCDT-Lung through training and validation datasets," said John Robertson, M.D., Professor of Surgery at Nottingham University, England, and Chief Scientific Officer of Oncimmune LTD. "The combination of this publication and the previous technical validation publications highlight the robust development program which Oncimmune has undertaken before launching the EarlyCDT-Lung test."


"Clinical Validation of an Autoantibody Test for Lung Cancer Diagnosis" was authored by Peter Boyle, PhD, Caroline J. Chapman, PhD, Stefan Holdenrieder, M.D., Andrea Murray, PhD, Chris Robertson, PhD, William C. Wood, M.D., Paul Maddison, M.D., Graham Healey, BSc, Geoffrey Hamilton Fairley, BSc, Anthony C. Barnes, Ph.D. and John F.R. Robertson, M.D.

(1) http://www.lungcancerfoundation.org/about-lung-cancer/fact-sheets/

(2) American Cancer Society

(3) American Lung Association

About Early Immuno-Biomarkers

Early immuno-biomarkers, in the form of autoantibodies, are produced in response to the presence of certain by-products from cancer cells (i.e., proteins called antigens). When the body recognizes something as "non-self" one of the ways it responds is for the immune system to produce large amounts of antibodies. The immune system does not normally produce antibodies against normal tissue antigens and therefore these immuno-biomarkers to cancer antigens provide high specificity for cancer. Tests that detect autoantibodies to a single tumor protein have been available for a number of years but have had low pickup 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.

About Oncimmune EarlyCDT-Lung

Oncimmune's EarlyCDT-Lung test uses a panel of tumor antigens to detect the presence of immuno-biomarkers produced in the form of autoantibodies by the patient's immune system. Elevation of any one of six immuno-biomarkers (autoantibodies) above a predetermined cutoff value suggests that a tumor might be present. This simple blood test aids in risk assessment and the early detection of lung cancer in high-risk patient populations. The key advantage of the test is its ability to detect cancer earlier, and with higher specificity, than spiral-CT which is the standard diagnostic imaging test used for these patients today. EarlyCDT-Lung is priced below a CT scan and as a simple blood test, eliminates radiation exposure from imaging screening techniques. High-risk individuals such as long-term smokers and ex-smokers between the ages of 40 and 75 and individuals with other risk factors such as environmental exposures and extensive exposure to secondary smoke are candidates for the test. Further research to investigate the most beneficial clinical use of the test (i.e., as a first test leading to further testing for those positive, or as a test providing further information to those who already have a CT identified nodule) is currently being finalized. EarlyCDT-Lung is CLIA (Clinical Laboratory Improvement Act) regulated. Other tests for breast, ovarian, esophagogastric, colon and liver cancers are planned. For more information about Oncimmune's EarlyCDT-Lung, visit: http://www.oncimmune.com.

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