A new test will be available by October 1st 2017.
Early cancer detection is key. You can increase your cancer survival rate through early cancer detection testing.
Early Cancer Detection Test Uses:
- Initial screenings
- Recurring cancer testing
- Familial cancer testing
- On-going screening during cancer treatments
Early cancer detection is done through the ONCOblot® blood test. The ONCOblot test helps detect early forms of cancer by identifying the ENOX2 protein, which only exists on the surface of malignant cancer cells. Cancer cells can be detected before symptoms appear and in early stages of development. Unlike other tests, the ONCOblot uses only one test to reveal all major forms of cancer. This test is highly sensitive and is a valuable tool in early diagnosis and early treatment of cancer.
Cancers Revealed by the ONCOblot Test:
- Large cell lung
- Small cell lung
- Malignant melanoma
Frequently Asked Questions
How much does the test cost?
The domestic price is $850.00 and is subject to change. Physician and/or blood draw fees are not included. Overnight domestic shipping fees for the test to be sent to the lab are included.
Is the test covered by insurance?
Not at this time—this is a new test.
How long does it take to get results back?
10-15 full business days.
What types of cancer does the ONCOblot® detect?
The database contains over 800 specimen containing examples of ENOX2 protein expression for more than 26 common malignant tumor types.
Do the results reveal more than one type of cancer in one test?
Yes. If there is more than one organ of origin, then more than one type of ENOX2 would be revealed and the results would indicate each organ of origin.
Do the results reveal metastasized cancer?
Refers to cancer that has spread from one part of the body to another. When cancer cells metastasize and form secondary tumors, the cells in the metastatic tumor have the same tissue of origin as those in the original (primary) tumor. Because the metastasized cancer is derived from the primary cancer, the metastasized cancer has the same ENOX2 as the organ of origin. Therefore, the metastasized cancer would be revealed in the test, but the organ of origin would remain the same as the primary.
Example: If breast cancer has metastasized to the lung, the test result would reveal only breast cancer.
Do the results provide stage of cancer?
No. The results show either presence of ENOX2 or no presence of ENOX2. There is no calculation for level or stage.
Do the results show tumor burden? (Refers to the number of cancer cells, the size of a tumor, or the amount of cancer in the body. Also called tumor load.)
No. Circulating ENOX2 levels determined by ONCOblot® are not necessarily proportional to tumor burden.
Does the test always reveal organ of origin?
Approximately 96% of the time, the test will reveal the organ of origin. There are times when ENOX2 is present, but it is fully processed, meaning that it does not provide a molecular weight and isoelectric point which enables identification of organ/site of origin.
How often should a person have the test?
This is a decision that is best made between the physician and the patient. It depends on the history of the patient, the treatment plans, etc.
How soon should the test be administered after treatment for cancer?
Enough time must be given for the circulating ENOX2 to clear from the system. One month should be satisfactory.
How accurate is the test?
Based on analyses of over 800 ONCOblots covering 26 different kinds of cancers with clinically confirmed diagnoses:
- 99.3% were positive for cancer based on ENOX2 presence
- Of these, the organ site of the cancer was determined correctly in 96% of the samples
- There were no false positives
- There were less than 1% false negatives
How does the ONCOblot test compare to other cancer blood tests?
Cancer tests currently available measure elevated levels of normal physiological compounds that are always present in serum. They are typically employed post clinical diagnosis and, for the most part, are not sufficiently sensitive for very early screening. The ONCOblot detects the presence of ENOX2. ENOX2 is not a normal protein in the serum. ENOX2 only exists in serum when cancer is present.
What are the requirements for the blood draw?
One tiger top tube of blood (included in the kit) should generate about 2mL of serum when spun. In the case where a phlebotomist has difficulty drawing a full tiger top tube, we would need a final serum volume of 100 microliters. Size of needle does not affect the protein (butterfly needles work). There are no special diet or drug requirements prior to the blood draw. The serum must be shipped with the ice pack (included in the kit) and shipped overnight to the lab Monday-Thursday only. The serum can be stored frozen indefinitely prior to shipping.
Is the test approved by the FDA?
The test currently meets FDA requirements for a Laboratory Developed Test (LDT).
How long has the test been available?
The ONCOblot® Test was CLIA registered in December 2011 and made available in January 2012.
Health Sciences Institute (HSI)
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