How It Works
What is the blood test based on?
The ONCOblot® blood test identifies a specific type of protein in the blood, 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 confirmation of cancer presence. The test is a valuable complement to early intervention.
How sensitive is the cancer blood test?
The ONCOblot® Test has been shown to detect cancer as early as Stage 0. The limit of detection is an estimated 2 million cells (2 mm or less tumor mass, roughly the size of a pinhead) compared to several billion cells for a positive mammogram.
How does this blood 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 of the blood test 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 tissue of origin.
In the example below, the circled spot indicates a lung cancer-specific ENOX2 protein. (The two spots labeled R are references used for calibration.)
What are the steps involved for the ONCOblot® Test?
The test kit is first delivered to your physician (must be ordered by a physician). Blood is then drawn and the completed test kit is sent to ONCOblot® Labs. Approximately 3 weeks (15 business days) are required for completion. The results are then sent back to your physician.
How is the ONCOblot® Test being used?
The ONCOblot® blood test can be used as a versatile addition to other cancer tests (such as high PSA, abnormal mammogram, suspicious PET scan). The blood test confirms biopsy results & detects cancer in high risk populations. The ONCOblot® cancer detection test can also be used to confirm post treatment effectiveness.
Is the ONCOblot® Test a Laboratory-Developed Test (LDT)?
ONCOblot® is a laboratory developed, CLIA Certified, CAP Accredited, blood serum test that meets current FDA guidelines. A 510(k) is being prepared for submission to the FDA, along with plans to seek insurance coverage.