Oncimmune to present benefits of EarlyCDT-Lung cancer test at ACCP annual meeting

Oncimmune (USA) LLCNov 1 2010

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."