Oncimmune® (USA) LLC has a single goal: To advance early cancer detection to the greatest extent possible using autoantibody assay technology through the Early Cancer Detection Test. To achieve this goal, we will strive to:
- Make the test available to at-risk individuals through their health care provider.
- Meet the highest levels of production and laboratory testing standards and ensure we meet or exceed CLIA requirements and standards.
- Continue developing EarlyCDT® for a wide range of cancers.
- Support university-based and other research efforts in autoantibody assay technology through The Centre of Excellence for Autoimmunity in Cancer (CEAC) at the University of Nottingham (UK).
- Provide value-added services and information to our clients and cancer advocacy groups to promote and support cancer prevention and early detection.
- A simple physician-ordered blood test to aid in risk assessment and the early detection of lung cancer in high-risk patients.
- EarlyCDT-Lung detects the body’s immune response, in the form of autoantibodies (or immuno-biomarkers), to antigens produced by solid-tumor cells.
- EarlyCDT-Lung aids in cancer detection by using a panel of tumor antigens that are selected for their involvement in the development of lung cancer.
- In healthy individuals, the immune system does not produce antibodies against normal tissue antigens. However, when cancer develops, cancer cells produce proteins with antigens that are abnormal or in some way modified from those found in normal tissue.
- The immune system detects these antigens and reacts by producing an abundance of autoantibodies that circulate in the bloodstream. As these autoantibodies form and circulate in the body at all stages of the disease including during Stages I and II, the earliest stages of lung cancer, their measurement signifies the presence of cancerous cells. The Oncimmune immuno-biomarker platform provides increased sensitivity while maintaining higher levels of specificity than other single or multiple antigen tests.
- Elevation of any one of the seven immuno-biomarkers above a predetermined cutoff value suggests that a tumor might be present.
- Early detection of lung cancer in high-risk patient populations are the primary benefits of EarlyCDT-Lung. It is also used as a diagnostic test for high-risk patients who have indeterminate lung nodules identified by CT.
- Used in conjunction with diagnostic imaging, EarlyCDT-Lung has the potential to aid in the identification of lung cancer at a very early stage when treatment can be most successful.
Oncimmune (USA) LLC, founded in 2006, is an industry leader in early cancer detection. In October 2013, Oncimmune LLC, a wholly-owned subsidiary of Oncimmune Ltd based in Nottingham, England, was substantially acquired by Health Diagnostics Laboratory, Inc (HDL) including the CLIA certified laboratory located in Kansas City. (Click here for full press release)
The company is committed to advancing early cancer detection through proprietary autoantibody assay technologies based on biological technology initially identified by John Robertson, M.D., professor of surgery at Nottingham University, England. Ongoing research and development is conducted by Oncimmune. 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. As a lab service, the Kansas City laboratory is a registered, high-complexity laboratory and is CLIA-certified under the Clinical Laboratory Improvements Amendment of 1988. We meet or exceed all CLIA regulations and are compliant with OSHA regulations. Testing is performed under license from Oncimmune Ltd which includes at least U.S. Patent No. 7, 402, 403. Oncimmune Ltd owns a worldwide portfolio of patents and related applications relating to its technology.
To see more Regulatory Information, please refer to the Reimbursement tab.