How the blood test works and how it is used
The IvyGene® test measures the methylation status of cell-free DNA extracted from blood samples at target sites that have been demonstrated to be hypermethylated when certain cancers are present. Test results are reported as a quantitative IvyGene® Score, which indicates the methylation status of the target sites. The IvyGene® Score is calculated as a composite average of cell-free DNA that is methylated at the target sites as a fraction of the total cell-free DNA present.
An IvyGene Score of 1-19 is considered normal. An IvyGene Score of 20 or greater is considered elevated.
Sensitivity of the IvyGene test is approximately 86% and Specificity of the IvyGene test is approximately 88%. These numbers are subject to change as the use for the IvyGene test to confirm the presence of additional cancer types are investigated.
Our laboratory has validated the IvyGene test with these 4 cancers: breast, colon, liver and lung. Preliminary testing for an additional 20 cancers has demonstrated an elevated IvyGene Score and as we complete the validation for additional cancers we will update this list.
Please note that an elevated Score does not necessarily mean that it is due to one of these 4 validated cancers. An elevated Score could be due to methylation associated with other cancers as well.
The IvyGene test does not provide tissue of origin. The IvyGene test analyzes DNA methylation to confirm cancer presence and give measurable information about cancer.
The IvyGene® test is an adjunct clinical test that is intended to be based on the independent medical judgement of the ordering physician in conjunction with the patient’s complete medical history and the results of standard of care testing. A large-scale clinical trial to demonstrate the efficacy of the IvyGene® Test as a cancer screening test has not been conducted. Cancer screening is not an approved utility of the IvyGene® test.
Logistics for Testing:
- Ask your physician to order a test kit
- Your physician will order the blood draw
- Completed test kits are sent overnight to the laboratory
- Results are sent to the ordering physician via email or fax within 5 business days
- IvyGene Report Example
The test currently meets FDA requirements for a Laboratory Developed Test (LDT). Our laboratory is CLIA Registered (Clinical Laboratory Improvement Amendments) and CAP Accredited (College of American Pathologists).