The ONCOblot Test Early Detection – Laboratory Developed Test (LDT) CLIA Accredited – CAP Accredited The ONCOblot® Test is a highly sensitive blood test for cancer. It identifies the presence of cancer as well as the organ site of origin through the detection of ENOX2 proteins. Provides early cancer detection: The ONCOblot® Test can detect the essential ENOX2 protein associated with cancer before clinical symptoms appear. The ENOX2 protein species in the blood is unique to malignant cells and these proteins can be detected at the earliest stages of development. Reveals origin of ENOX2 protein according to tissue or organ: The ONCOblot® Test reveals the tissue of origin of the ENOX2 protein which in turn your physician uses to identify the exact kind of cancer arising: Lung Liver Breast Prostate Colon Bone Skin Blood Lymphatic Pancreatic Ovarian Cervical Provides accurate information your physician may use to render the proper diagnosis: The ONCOblot® Test identifies the ENOX2 markers that are only produced by cancer cells and absent from non-cancer cells. The direct visualization of a marker presence eliminates false positives. Delivers value: ONCOblot® does the work of more than 10 tests normally costing $100 to $200 each, none of which directly detect ENOX2. The test must be prescribed by a physician. How the ONCOblot® Test Works What is the test based on? The ONCOblot® Test identifies a specific type of protein, ENOX2, which exists only on the surface of a malignant cancer cell. The ENOX2 proteins are shed into the circulation and can be detected in the blood. These proteins serve as highly sensitive markers for your physician to make an accurate early detection in both primary and recurrent cancer. The test is a valuable complement to early intervention. How sensitive is the test? The ONCOblot® Test is highly sensitive. It will detect ENOX2 proteins when only 2 million cancer cells are present compared to 4.5 trillion cells for a positive mammogram. How does the test determine organ site? The ONCOblot® Test uses techniques known as two-dimensional gel electrophoresis and western blot analysis along with an ENOX2 protein-specific antibody for detection. The result is presented visually on the ONCOblot®. Each type of ENOX2 has a specific location (molecular weight and isoelectric point) on the blot to demonstrate ENOX2 presence and to identify the organ site. What are the steps involved for the ONCOblot® Test? • Test kit delivered to physician • Blood drawn (may be performed at local clinical laboratory) and sent to ONCOblot® Labs • Approximately 2 week testing period • Results sent to physician How is the ONCOblot® Test used? • Initial screening of patient • To help discover recurrence • Familial cancer screening • On-going screening during cancer treatments Laboratory-Developed Test (LDT): ONCOblot® is a laboratory developed, CLIA-registered blood serum test that meets current FDA guidelines. Early Trial Results: Midcourse evaluation in November 2011 of 100 subjects enrolled in an early detection trial revealed the following trends: • Of 92 subjects presenting with no clinical symptoms, 56 subjects or 60% were negative in the ONCOblot® test. • Of the same 92 subjects presenting with no clinical symptoms, 36 subjects or 40% were positive in the ONCOblot® test. This aligns with current data of 1 in every 3 individuals is expected to contract cancer in their lifetime. • Of the 36 subjects with markers testing positive for early stages, 12 were identified by a physician as non-small cell lung cancer, 7 as breast cancer, 6 as lymphoma/leukemia, 1 each for ovarian, melanoma, prostate and colon, and 7 having transcript variants not yet in the database. Insurance Reimbursement: Currently, Medicare and insurance carriers do not cover ONCOblot® testing since the test is so new. However, ONCOblot® is being evaluated by insurance carriers for reimbursement and may in the near term offer coverage. So stay tuned!