Given the RML relationship, along with our growing base of partners in the US, we believe that we can improve the outlook and well-being for countless individuals who are at increased risk for developing lung cancer.
(PRWEB) April 09, 2013
Regional Medical Laboratory (RML) announced today that it has recently entered into an agreement with Oncimmune® USA LLC to offer EarlyCDT-Lung to their client base. EarlyCDT-Lung is a ground-breaking blood test that aids in the risk assessment and the early detection of lung cancer.
“Oncimmune is pleased with the new RML partnership and the ability it offers in bringing EarlyCDT-Lung to their physicians,” said Greg Stanley, Chief Commercial Officer at Oncimmune USA. “Given the RML relationship, along with our growing base of partners in the US, we believe that we can improve the outlook and well-being for countless individuals who are at increased risk for developing lung cancer.”
Lung cancer is the leading cause of cancer deaths among men and women in the United States. It takes the lives of more people each year than colon, breast, prostate and pancreatic cancers combined. Lung cancer claims over 3 times as many men as prostate cancer and nearly 2 times as many women as breast cancer. In 2012, over 226,000 new cases of lung cancer were diagnosed and over 160,000 perished from the disease.
The performance and clinical utility of EarlyCDT-Lung test is supported by 17 peer-reviewed publications, click here. The test has a high specificity (93%), seven times fewer false positives and seven times better positive predictive value (PPV) than CT. Additionally, the test offers >91% accuracy, when considering a population with 2% prevalence of lung cancer (20 lung cancers per thousand).
Currently, numerous leading academic institutions, as well as more than 2,000 physicians throughout the United States are offering the test. A prospective audit of clinical data from the first 1,600 patients tested by EarlyCDT-Lung validates its utility to detect early-stage lung cancer and its overall performance, click here. Additionally, the Scottish government is conducting a 10,000-patient randomized clinical trial to validate the economic benefit of the test in screening high-risk patients, click here.
Patient blood samples sent to RML will be analyzed at Oncimmune’s CLIA-certified laboratory located in De Soto, Kansas.
Regional Medical Laboratory is a nationally-renowned commercial pathology laboratory that provides testing services for thousands of physicians and hospitals within a four-state region. The highest standard of quality is maintained through a vigorous quality assurance program including certification by the College of American Pathologists, the Oklahoma State Department of Health, the United States Department of Health and Human Services, and registration with the Food and Drug Administration. Regional Medical Laboratory employs experienced technologists, pathologists and support staff who use the latest technology and make every effort to ensure that every test result is accurate. Regional Medical Laboratory performs more than seven million procedures each year.
Oncimmune (USA) LLC, founded in 2006, is an industry leader in early cancer detection. Oncimmune is a privately funded company located in Nottingham, UK with US headquarters and a CLIA laboratory located just outside of Kansas City. The company launched a proprietary platform technology for early cancer detection, called EarlyCDT®. The first commercially available test, EarlyCDT®-Lung, a blood test to aid in the early detection and risk assessment of lung cancer, was released in 2009. The company’s mission is to develop early cancer detection tests to identify more than 90 percent of solid-tumor cancers, which make up 70 percent of all cancers including lung, breast, colorectal, prostate, stomach, pancreatic and ovarian.
EarlyCDT-Lung – is a simple blood test that detects cancer at its earliest stages of development. EarlyCDT-Lung has been shown to detect early and late stage cancers in research studies as well as in clinical use. An audit of more than 1,600 patients, confirms the test performs in the clinical setting as expected. Oncimmune’s EarlyCDT-Lung test uses a panel of tumor antigens to detect the presence of immuno-biomarkers (autoantibodies) produced by the patient’s immune system when lung cancer is present. Elevation of any one of the panel of immuno-biomarkers (autoantibodies) above a predetermined cut-off value suggests that a tumor might be present. Previous studies have shown that immuno-biomarkers, in some cases, can be detected up to five years earlier than tumors can be seen in routine diagnostic imaging procedures. Tests that detect autoantibodies to a single tumor protein have been available for a number of years but have had low detection 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. The test is performed in Oncimmune’s CLIA-certified laboratory just outside the Kansas City metro area.