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Studies Demonstrate Early Stage Detection and Economic Benefits of a Blood-Based Test for Lung Cancer
Date:6/1/2010

KANSAS CITY, Kan., June 1 /PRNewswire/ -- Oncimmune LLC, maker of EarlyCDT-Lung™, a simple blood test that aids physicians in risk assessment and the early detection of lung cancer, today announced validation study results demonstrating the diagnostic and economic benefits of a standardized and reproducible autoantibody laboratory test (AABT) that may significantly improve the prognosis for lung cancer patients. Currently, lung cancer is responsible for more deaths than breast, prostate, colon, liver, kidney and melanoma cancers combined.(1)

Studies were completed with 573 patients known to have lung cancer who were matched against normal patients (no lung cancer) for the same age, sex and smoking history. The test, which is regulated under CLIA, has 40% sensitivity and 90% specificity. This means that the test detects 40% of lung cancers, including early stage disease (Stages I and II), and the overall accuracy of the test is greater than 88%. This performance compares favorably with other well known tests such as mammography in younger women or in the case of lung cancer, where EarlyCDT-Lung performance is at least twice as good as CT. Study findings suggest that the autoantibody test is not influenced by sex, ethnicity, geographic location of patients or the presence of benign autoimmune diseases. Previous studies have shown that autoantibodies can be detected up to five years before tumors can be seen in routine diagnostic imaging procedures such as CT.(2)

Oncimmune researchers also set forth the modeled cost-effectiveness of EarlyCDT-Lung as an aid to lung cancer diagnosis, with an estimated $6,000 potential cost savings for every QALY (quality-adjusted life year) saved. Study results are being introduced in multiple poster presentations June 6, 2010, at the annual meeting of the American Society of Clinical Oncology.

"Oncimmune's extensive research has shown that solid tumors can initiate an immune response resulting in measurable levels of autoantibodies (immuno-biomarkers) that can be detected in the peripheral blood. Ultimately this provides biological information critical to enabling earlier cancer detection and potentially changing the current paradigm of diagnosis and treatment for most solid tumors including lung and breast, among others," said John Robertson, M.D., Professor of Surgery at Nottingham University, England, and Chief Scientific Officer of Oncimmune LTD. According to the American Cancer Society, a lung cancer patient's best chance of survival is early detection.(3) EarlyCDT-Lung has the potential to identify the very early stages of lung cancer when treatment can be most successful.

"I am impressed with the precision and reliability this test shows in studies involving hundreds of cancer patients and controls. It has been known for some time that autoantibodies are sensitive early indicators of cancer. EarlyCDT-Lung allows testing people at high risk for lung cancer in order to identify a group who may already have occult, curable tumors on the basis of a simple positive result," said William C. Wood, M.D., Professor of Surgery, Division of Surgical Oncology, Department of Surgery, Emory University School of Medicine.

In 2009, Oncimmune launched its EarlyCDT-Lung test to a limited number of office-based physicians in the Midwest and Southeast. Currently, nearly 500 physicians in more than 80 practices offer EarlyCDT-Lung to test their high-risk patients.  

The following investigational presentations reflect Oncimmune-sponsored lung cancer studies presented at this year's ASCO Annual Meeting:

  • "Use of serum autoantibodies to identify early-stage lung cancer: A significant step forward in early detection" Sunday, June 6, 2010, 8 a.m.–12 noon, S Hall – A2, Poster #19F. Abstract authors: Laura J. Peek, Ph.D., Oncimmune USA LLC; Stephen Lam, British Columbia Cancer Agency; Graham Healey, Oncimmune LTD; Herbert A. Fritsche, Ph.D., UT MD Anderson Cancer Center; Caroline Chapman, Division of Breast Surgery, University of Nottingham; Andrea Murray, Oncimmune LTD; Paul Maddison, University Hospitals NHS Trust; John F. R. Robertson, MD, MBBS, Division of Breast Surgery, University of Nottingham; and William Wood, Emory University School of Medicine.

  • "Demographics of populations at high risk of lung cancer and results of the EarlyCDT-Lung™ Test" Sunday, June 6, 2010, 8 a.m.–12 noon, S Hall – A2, Poster #19 G. Abstract authors: John Mathew, MS, FRCS, Division of Breast Surgery, University of Nottingham; Graham Healey, Oncimmune LTD; William Jewell, Oncimmune USA LLC; Andrea Murray, Oncimmune LTD; Caroline Chapman, Division of Breast Surgery, University of Nottingham; Laura J. Peek, Ph.D., Oncimmune USA LLC; Anthony C. Barnes, Ph.D., Rules-Based Medicine; William Wood, Emory University School of Medicine; John F. R. Robertson, MD, MBBS, Division of Breast Surgery, University of Nottingham; and Peter Boyle, International Prevention Research Institute.

  • "Cost-effectiveness of an autoantibody test (AABT) as an aid to diagnosis of lung cancer" Sunday, June 6, 2010, 8 a.m.–12 noon, S Hall – A2, Poster #19D. Abstract authors: Derek Weycker, Ph.D., Policy Analysis, Inc. (PAI); James R. Jett, M.D., Medical Oncology, Mayo Clinic; Frank C. Detterbeck, MD, Yale School of Medicine; Daniel L. Miller, MD, Emory University School of Medicine; Anne Khuu, Policy Analysis, Inc. (PAI); Timothy C. Kennedy, University of Colorado Denver, Cancer Center; Peter Boyle, International Prevention Research Institute; John F. R. Robertson, MD, MBBS, Division of Breast Surgery, University of Nottingham; Geoffrey Hamilton-Fairley, Oncimmune LTD; and John Edelsberg, MD, MPH, Policy Analysis, Inc. (PAI).

Copies of the above poster abstracts are available at the Oncimmune ASCO booth # 19140 or by accessing Oncimmune's web site at http://www.oncimmune.com.

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 asymptomatic 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 .  

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

(2) Zhong L, Coe SP, Stromberg AJ, et al.: Profiling tumor-associated antibodies for early detection of non-small cell lung cancer. J Thor Oncol 1:513–519, 2006.

(3) American Cancer Society.


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