SOURCE: Oncimmune (USA) LLC

June 29, 2010 11:05 ET

Oncimmune® EarlyCDT-Lung™ -- a Simple Blood Test to Aid in the Early Detection of Lung Cancer -- Now Available in Canada

KANSAS CITY, KS--(Marketwire - June 29, 2010) -  Oncimmune LLC, provider of EarlyCDT-Lung, a simple physician-ordered blood test that aids physicians in the risk assessment and early detection of lung cancer in high-risk patients, most notably long-term smokers or former smokers, today announced that the test is now commercially available in Canada after receiving strong interest from Canadian physicians at the American College of Physicians meeting in Toronto in May, and numerous inquiries from consumers. 

EarlyCDT-Lung is a blood test that measures autoantibodies (immuno-biomarkers) in blood which are produced by the body in response to tumor antigens which are produced by cancer cells at the earliest stages of the disease, before tumors show up on CT or X-ray. Dr. John Robertson, Professor of Surgery at the University of Nottingham and Chief Scientific Officer at Oncimmune LTD, said, "We believe that detecting lung cancer in Stages I and II could potentially increase survival rates from lung cancer from 16% to 53%, based upon NIH/NCI data. This test has been carefully developed and studied for specificity, sensitivity, accuracy, reproducibility and precision."

There is a large body of work that supports the Oncimmune test premise that autoantibodies to lung cancer antigens arise at the earliest stages of the disease and are present in sufficient quantity to be measured. To maximize performance for lung cancer detection, EarlyCDT-Lung consists of a panel of six tumor antigens: p53, NY-ESO-1, CAGE, GBU4-5, Annexin 1 and SOX2.

EarlyCDT-Lung underwent rigorous testing and over the course of five years more than 80,000 assays have been performed. Final protocols and cutoff values were determined using 1,000 samples and an independent sample set of over 1,500 samples.

Oncimmune provides all of the necessary materials and information for patients and physicians. To request a kit, patients may contact Oncimmune via the company's Web site at www.oncimmune.com. Physicians may request more information at www.oncimmune.com/index.php?tab=physician or by telephone at 1-888-583-9030. The blood sample is sent to Oncimmune's CLIA-certified laboratory in De Soto, Kansas (Kansas City metropolitan area), and the results are reported to the ordering physician within 7-10 days after the sample is received.

Oncimmune recently presented three scientific posters at the American Society of Clinical Oncology (ASCO) meeting in Chicago in early June, which showed the technical, clinical, and economic benefits of EarlyCDT-Lung and resulted in further inquiries by Canadian physicians attending the conference. Other published data are available on their website.

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-certified 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

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