Abstracts Reporting EarlyCDT™-Lung Demonstrate Diagnostic and Economic Benefits of Immuno-biomarkers in Early Detection of Solid Tumor Lung Cancers

VANCOUVER, British Columbia, Nov. 1, 2010 /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 announced that two oral presentations and five poster presentations during this week's American College of Chest Physicians' (ACCP) annual meeting in Vancouver will collectively highlight the clinical and economic benefits of 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 panel of immuno-biomarkers (autoantibodies) above a predetermined cut-off value suggests that a tumor might be present.  

These studies follow data presented at the American Society of Clinical Oncology (ASCO) earlier this year. The studies presented this week at CHEST reaffirm EarlyCDT-Lung's performance with additional data sets.  Various studies, including those presented this week at CHEST, validate that EarlyCDT-Lung detects all types of lung cancers at all stages, including early stage disease. 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 CT(1).

Subsequent to the studies presented here, Oncimmune has added 2 new antigens to the EarlyCDT-Lung panel, for a total of eight autoantibody assays. The test now has a greater than 90% accuracy, three times better positive predictive value than computed tomography (CT), with seven times fewer false positives. These data will be published soon.

"We are very pleased to have the opportunity at this CHEST meeting to show more EarlyCDT-Lung data," Professor John Robertson, MD, FRCS, Chief Scientific Officer and founder of Oncimmune and Professor of Surgery, City Hospital, Nottingham University, United Kingdom.  "Recent publications of validation data in the Annals of Oncology, three posters at ASCO, along with the two oral presentations and five posters at ACCP, clearly demonstrate the depth of our scientific data and its reproducible performance. We are publishing a number of new papers in the next twelve months that further underpin our scientific credentials. All this should lead, I hope, to early adoption of EarlyCDT-Lung so that we can help patients in the diagnosis of lung cancer at an earlier stage and thus improve prognosis."

According to Professor Peter Boyle, PhD, International Prevention Research Institute, Lyon, France, and presenter of one of two Oncimmune oral presentations, "I have followed Oncimmune's progress since its inception and latterly as a member of the company's independent Scientific Advisory Board. The company has always adhered to rigorous scientific disciplines in its work.  The end result is a real and effective test for the early detection of lung cancer and supports decision making over the management of lung nodules. I will be presenting one aspect at this year's CHEST meeting that shows that EarlyCDT-Lung detects immuno-biomarkers at all stages of lung cancer, including stages 1 & 2. This simple blood test can help us find lung cancer earlier. By catching the cancer earlier, treatment is more likely to be successful. It has been invaluable to have the health economics of the test carefully examined by an independent firm of heath economists; their analysis shows that it is cost effective for both screening and CT nodule risk stratification."

The following presentations reflect Oncimmune-supported lung cancer studies presented at this year's ACCP Annual Meeting:

Oral Presentations:

Diagnosis and Evaluation in Lung Cancer:  November 1, 8 a.m. – 9:15 a.m., Session ID 6065, Convention Center 118

• "Antigen Positivity in the EarlyCDT-Lung Test by Stage and Histological Subtype of Lung Cancer,"   Peter Boyle, PhD, Stephen Lam, MD, Paul Maddison, MD, William C. Wood, MD, Laura J. Peek, PhD, Andrea Murray, PhD, Caroline J. Chapman, PhD,  Graham Healey, BSc, and John Robertson, MD

Speaker:  Peter Boyle, PhD, Lyon, France

Evolving Basic Science Strategies in Lung Cancer Evaluation:  November 1, 4:30 p.m. – 6 p.m., Session ID 6067, Convention Center 114 – 115

• "The Presence of Autoantibodies to Tumour-Associated Antigens can Predate Clinical Diagnosis of Small Cell Lung Cancer," Caroline Chapman, PhD, John Robertson, MD, Andrea Murray, PhD, Maarten Titulaer, MD, Bethan Lang, PhD, Alison Thorpe,  MSc, Paul Gozzard, BAMBBChirMRCP, Jan Verschuuren, MD, PhD, and Paul Maddison, MD

Speaker:  Caroline Chapman, PhD, Nottingham, United Kingdom.

Poster Presentations

Lung Cancer Diagnosis and Evaluation Posters: All November 2, 12:45 p.m. – 2:00 p.m., Convention Center Clinical Resource Center

• "Reproducibility of Autoantibody Measurements in Normal Individuals Using the Early CDT-Lung Test," Poster #384, Abstract ID: 10483

Andrea Murray, PhD, Graham Healey BSc, Caroline Chapman, PhD, George Parsons PhD, Laura J. Peek, PhD, Jared Allen, MSci, Jane McElveen, BSc, and John Robertson, MD

Presenter:  Andrea Murray, PhD, Nottingham, United Kingdom

• "Identification of Tumor-Associated Autoantibodies in Small Cell Lung Cancer as Immune Markers of Disease," Poster # 370, Abstract ID: 10487  

Caroline Chapman, PhD , Paul Maddison, MD, Andrea Murray, PhD, Alison Thorpe MSc, Celine Parsy-Kowalska, PhD, and John Robertson, MD  

Presenter:  Caroline Chapman, PhD, Nottingham, United Kingdom

• "Early CDT-Lung: QC Measures Reveal High Precision, Accuracy, and Robustness for a Clinical Test To Aid in Early Lung Cancer Detection for High-Risk Individuals," Poster # 386, Abstract ID: 10503

Laura J. Peek, PhD, Graham Healey, BSc, Andrea Murray, PhD, and John Robertson, MD

Presenter:  Laura J. Peek, PhD, Kansas City, Kansas

• "An Autoantibody Test (AABT) To Aid in Early Detection of Lung Cancer in High-Risk Patients Is Likely To Be Cost-effective," Poster #383, Abstract ID:  10709

Peter Boyle, PhD, Derek Weycker, PhD, Anne Khuu, James R. Jett, MD, Frank C. Detterbeck, MD, Timothy C. Kennedy, MD, Daniel L. Miller, MD, Herbert Fritsche, PhD, William C. Wood, MD, Geoffrey Hamilton-Fairley, John Robertson, MD, John Edelsberg, MD, MPH

Presenter:  Peter Boyle, PhD, Lyon, France

• "Stage 1a Non-small Cell Lung Cancer Detected by Assaying Autoantibodies to Tumor Antigens," Poster # 357, Abstract ID:  10544

Keith E. Kelly, MD and William H. Culbertson, MD

Presenter:  Keith Kelly, MD, Paducah, Kentucky

The full abstracts can be accessed through the ACCP Web site and the Oncimmune Web Site following ACCP.  

"Having a significant presence at CHEST is a wonderful milestone for our test, EarlyCDT-Lung," commented Dan Calvo, President and CEO of Oncimmune USA. "This further validation of our test's performance, and its clinical and economic impact, supports the increasing interest in our test by the medical community.  This has particular relevance today since November is Lung Cancer Awareness Month and ACCP is supporting 2010: Year of the Lung and early detection is such a critical element of improving outcomes against this terrible disease."

The Year of the Lung is a global initiative instituted by the Forum of International Respiratory Societies (FIRS), a collaboration of the world's leading professional respiratory organizations, including the ACCP.   2010: The Year of the Lung aims to raise awareness of and advocate for lung health, globally and at the country level, to reduce lung disease morbidity and mortality.

(1) 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.

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 immuno-biomarkers (autoantibodies) in the panel 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