A new noninvasive blood test uses advanced DNA sequencing methods to confirm and detect the presence of cancer when other cancer screens show the possible presence of a cancer. Common cancers (breast, colon, liver and lung) can be detected with the test which can supplement other tests. If positive, further follow-up diagnostic and screening tests may need to be ordered. It may also be used to monitor cancers in people with known cancers present.
The test detects an abnormal compound produced by cancer cells (an abnormal methyl grouping). Thus, normal cells with a normal methy grouping are distinguished from the cancer cells with this test. The abnormal methylation group is determined by the abnormal DNA of the cancer cells. Thus, you could say it measures the byproducts of cancer cell’s DNA. Learn more on the video on the right.
Although not classified as a cancer screening test, it can assist in evaluating patients who had abnormal findings or for monitoring. For instance, if a screening mammogram is questionable, this could assist in further evaluation.
The test has been validated for the detection of cancers as early as stage 1. It has not been investigated for the detection of pre-cancers or stage 0 cancers.
The test carries a 86% sensitivity and the specificity is around 90%. An elevated IvyGene Score means that the amount of abnormal methylation present is consistent with the presence of cancer. The quantity of the test results does not necessarily correlate to the stage of cancer if positive. Nor will it tell you if metastasis are present.
Presently, the IvyGene test is not FDA approved, but it meets FDA requirements to be marketed as a Laboratory Developed Test (LDT). Thus, the test is not covered under insurance.
For further information, check out the IvyGenelabs.com website.
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. The IvyGene® Test has been validated with four (4) cancer tissues of origin: breast, colon, liver and lung cancers. The presence of other cancer types may also result in an elevated IvyGene® Score. 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.
Cancers progress at varying rates and therefore, the frequency of diagnostic testing is subject to the ordering Provider’s clinical judgement.
Please, note that the IvyGene test does not “Stage” cancers, but rather provides quantifiable data about disease presence.