First Reportable Data of EarlyCDT™-Lung Use in Clinical Practice Presented at IASLC World Conference on Lung Cancer One-thousand patient audit demonstrates results consistency for simple blood test that aids physicians in early detection of lung cancer, including characterization of indeterminate pulmonary nodules

AMSTERDAM, July 5, 2011 /PRNewswire/ -- Oncimmune® LLC, maker of EarlyCDT™-Lung, a simple blood test that aids physicians in the risk assessment and early detection of lung cancer, today announces that an abstract (P4.013) "EarlyCDT-Lung test: audit of 1,000 patients in clinical practice" supports the previously published validation studies on EarlyCDT-Lung with sensitivity for non-small cell lung cancer (NSCLC) at least as high as in the validation studies, including early stage disease. Leading lung cancer expert, James Jett, M.D., National Jewish Health, presents these findings Thursday, July 7, 2011, from 10:00 a.m. - 12:30 p.m. at Exhibition Hall, Amsterdam Rai, The Netherlands.  The complete abstract can be accessed and viewed on the IASLC World Conference on Lung Cancer web site at http://www.2011worldlungcancer.org/abstracts.html.

"The EarlyCDT-Lung test is a new technology with the potential to shift our ability to diagnose lung cancer earlier than is currently achieved," said James Jett, M.D., Professor of Medicine, National Jewish Health.  "Data auditing the use of the test in clinical practice are consistent with the case-controlled studies. These data indicate that the EarlyCDT-Lung test can risk stratify normal versus malignant nodules.  The current guidelines that pulmonologists use for risk stratification and guiding the monitoring of CT nodules (Fleischner guidelines) are not as precise as we would like and any tool that allows us to further risk stratify these nodules is of value," he added.  

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 the panel of immuno-biomarkers (autoantibodies) above a predetermined cut-off value suggests that a tumor might be present and the lung nodule is malignant.  Previous studies have shown that immuno-biomarkers can be detected up to five years before tumors can be seen in routine diagnostic imaging procedures such as computed tomography (CT).

The audit included results from EarlyCDT-Lung's initial 6-antigen panel and the current 7-antigen panel that enables greater than 90% accuracy.  EarlyCDT-Lung has 93% specificity, resulting in seven times fewer false positives and three times better positive predictive value than CT. One thousand and ten (1010) patients in North America at high risk of lung cancer, on the basis of age and smoking history, from 293 centers across 40 states had EarlyCDT-Lung measured (start date May 2009). All patients signed a HIPAA release agreeing to their clinical information being accessed as part of this prospective audit.

According to John Robertson, M.D., FRCS, Chief Scientific Officer and founder of Oncimmune and Professor of Surgery, City Hospital, University of Nottingham, United Kingdom, "Collective data published in the Annals of Oncology, Clinical Cancer Research and an 'in press' manuscript with Cancer Prevention Research continue to demonstrate the depth of our scientific data and its reproducible performance.  Early lung cancer detection can save lives, as highlighted in last week's New England Journal of Medicine publication of the NLST trial, which compared spiral-CT to X-ray in high risk patients. It is our hope that this body of work will lead to the early adoption of EarlyCDT-Lung, which can help physicians diagnose lung cancer at an earlier stage more cost-effectively, and also reduce the number of false positives associated with CT."

The National Lung Screening Trial (NLST) compared two ways of detecting lung cancer: low-dose helical computed tomography (CT) and standard chest X-ray.  NLST enrolled 53,454 current or former heavy smokers from 33 sites and coordinating centers across the United States.  The findings reveal that participants who received low-dose helical CT scans had a 20 percent lower risk of dying from lung cancer than participants who received standard chest X-rays.

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 proteins 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 the immuno-biomarkers (autoantibodies) in the panel above a predetermined cutoff value suggests that a tumor might be present, even before lung cancer symptoms may appear. 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 second-hand smoke are candidates for the test. One of the smoking effects is a higher propensity for developing lung cancer, and patients who smoke or formerly smoked should be examined closely. 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 lung nodule) is currently being finalized. EarlyCDT-Lung is performed exclusively within Oncimmune's CLIA (Clinical Laboratory Improvement Act) regulated laboratory in DeSoto, Kansas. 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 at Oncimmune's CLIA (Clinical Laboratory Improvement Act) regulated laboratory located 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



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