Oncimmune® LLC, provider of EarlyCDT-Lung™, announces the publication of a study that demonstrates the clinical validity of the test.
The study titled "Clinical Validation of an Autoantibody Test for Lung Cancer Diagnosis" is now available on line at Annals of Oncology, Oxford Journals, or at Oncimmune’s [removed]Web site[/removed]. Annals of Oncology is the official journal of the European Society for Medical Oncology and is also affiliated with the Japanese Society of Medical Oncology.
The study reports that EarlyCDT-Lung, which measures six autoantibodies to select cancer-associated antigens, detects up to 40% of lung cancers, including early stage disease (Stages 1 and 2) with a specificity of 90% and an overall accuracy of 88%. The performance of EarlyCDT-Lung is comparable to mammography in young women at high risk of breast cancer and also colonoscopy in individuals at high risk of colon cancer. Both small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) were detected by EarlyCDT-Lung. The presence of benign lung disease did not impact the high specificity of the test.
Timothy C. Kennedy, MD, Clinical Professor, University of Colorado School of Medicine, commented about EarlyCDT-Lung and this new data, "It is intriguing to consider the possible impact these test characteristics may have on the management of patients at high risk for lung cancer with suspicious CT imaging results. The positive predictive value is very good and should aid further risk stratification when considering any ongoing monitoring options. The sensitivity is pretty good. Much work needs to be done before the test’s impact on lung cancer specific mortality can be determined, especially in the area of early detection."
Previous published studies had focused on the technical performance of the test reporting that EarlyCDT-Lung is a reproducible autoantibody (immuno-biomarker) laboratory test, which gave similar results in training and validation datasets. The present publication extends these findings and in particular highlights that EarlyCDT-Lung detects early stage lung cancer that may significantly improve the prognosis for lung cancer patients.
Currently in the United States, lung cancer is responsible for more deaths than breast, prostate, colon, liver, kidney and melanoma cancers combined1. The 5-year survival rate of approximately 16% has remained essentially unchanged over the last 40 years, due in part to the lack of early detection2. According to the NCI, the 5-year survival rate triples to over 50% if the disease is treated when it is localized and caught at an early stage3.
Source: OncImmune
1 [removed]http://www.lungcancerfoundation.org/about-lung-cancer/fact-sheets/[/removed]
2 American Cancer Society
3 American Lung Association
