New Study Demonstrates Clinical Validity of EarlyCDT-Lung™

KANSAS CITY, Kansas, Aug. 5 /PRNewswire/ -- Oncimmune® (USA) LLC, provider of EarlyCDT-Lung™, a simple blood test that aids physicians in risk assessment and the early detection of lung cancer, today announced the publication of a study that demonstrates the clinical validity of the test. The study titled "Clinical Validation of an Autoantibody Test for Lung Cancer Diagnosis" is now available on line at Annals of Oncology, Oxford Journals, or at Oncimmune's web site: http://www.oncimmune.com/physicians-healthcare-professionals/papers-and-publications/.  Annals of Oncology is the official journal of the European Society for Medical Oncology and is also affiliated with the Japanese Society of Medical Oncology.  

The study reports that EarlyCDT-Lung, which measures six autoantibodies to select cancer-associated antigens, detects up to 40% of lung cancers, including early stage disease (Stages 1 and 2) with a specificity of 90% and an overall accuracy of 88%.  The performance of EarlyCDT-Lung is comparable to mammography in young women at high risk of breast cancer and also colonoscopy in individuals at high risk of colon cancer. Both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) were detected by EarlyCDT-Lung. The presence of benign lung disease did not impact the high specificity of the test.

Timothy C. Kennedy, M.D., Clinical Professor, University of Colorado School of Medicine, commented about EarlyCDT-Lung and this new data, "It is intriguing to consider the possible impact these test characteristics may have on the management of patients at high risk for lung cancer with suspicious CT imaging results.  The positive predictive value is very good and should aid further risk stratification when considering any ongoing monitoring options.  The sensitivity is pretty good.  Much work needs to be done before the test's impact on lung cancer specific mortality can be determined, especially in the area of early detection."

Previous published studies had focused on the technical performance of the test reporting that EarlyCDT-Lung is a reproducible autoantibody (immuno-biomarker) laboratory test, which gave similar results in training and validation datasets.  The present publication extends these findings and in particular highlights that EarlyCDT-Lung detects early stage lung cancer that may significantly improve the prognosis for lung cancer patients.

Currently in the United States, lung cancer is responsible for more deaths than breast, prostate, colon, liver, kidney and melanoma cancers combined(1). The 5-year survival rate of approximately 16% has remained essentially unchanged over the last 40 years, due in part to the lack of early detection(2). According to the NCI, the 5-year survival rate triples to over 50% if the disease is treated when it is localized and caught at an early stage(3).

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.  

About Oncimmune LLC

Oncimmune (USA) LLC, founded in 2006, is an industry leader in early cancer detection. The company is committed to advancing early cancer detection through proprietary immuno-biomarker technologies based on biological technology identified by John Robertson, M.D., Professor of Surgery at Nottingham University, England, and Chief Scientific Officer of Oncimmune LTD. Ongoing research and development is conducted by Oncimmune under the direction of Professor Robertson. The company's mission is to develop early cancer detection tests to identify more than 90% of solid-tumor cancers, which make up 70% of all cancers including lung, breast, colorectal, prostate, stomach, pancreatic and ovarian. All testing is performed exclusively within Oncimmune's CLIA-registered laboratory located in De Soto, Kansas, in the metro Kansas City area. Oncimmune LLC is a wholly owned subsidiary of Oncimmune LTD. Oncimmune LTD owns a portfolio of patents, including Patent Nos. 7,402,403 and 7,205,117, with five others currently filed and under review. For more information about Oncimmune, visit: http://www.oncimmune.com.  

SOURCE Oncimmune (USA) LLC