The IvyGene™ Cancer Blood Test measures the methylation status of cell-free DNA at target sites that have been demonstrated to be hypermethylated when certain cancers are present. Cancer Blood 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.
Cell Free DNA
DNA of cells is shed into the blood due to cancer cell death (apoptosis or necrosis). Once the genomic DNA of a cell is shed into the blood stream, it is called cell-free DNA (cfDNA). This cfDNA retains the DNA methylation pattern of the cell from which is was shed.
Similarly, genomic DNA of cancer cells is shed into circulation and retain the methylation patterns of those cancer cells. Once the genomic DNA of a cancer cell is shed into the blood stream, it is called circulating-tumor DNA (ctDNA).
Methylation is an epigenetic mechanism. DNA within cells may be modified by the addition of a methyl group (-CH3) to certain sites within the genome. This type of DNA modification is not a mutation that alters the coding potential of the genome. Instead, this type of DNA modification acts as a heritable but reversible marker of gene expression, called an epigenetic marker.
Methylation at specific sites in DNA correlates with the presence of cancer. During malignant transformation (the process by which normal cells transform into cancer cells), there are significant changes in gene expression.
These changes in gene expression are highly correlated to changes to the methylation pattern of genomic DNA. Therefore, normal cells and cancer cells can be differentiated by detecting which sites within the genome are methylated.
The IvyGene technology provides a highly accurate way to confirm the presence of cancer and give measurable information about cancer. The sensitivity of the IvyGene Cancer Blood Test is approximately 84% and Specificity of the IvyGene test is approximately 90%. Our laboratory has validated the IvyGene Cancer Blood 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.
The sensitivity of the IvyGene Liver Cancer Test is 80% and the specificity is 86%.
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.
The IvyGene Cancer Blood Test does not provide the tissue of origin.
The IvyGene Cancer Blood Test analyzes DNA methylation to confirm cancer presence and give measurable information about cancer.