Science

Overview

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.

 
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Underlying Science

DNA of cancer cells is shed into the blood. The genomic DNA of cancer cells is shed into circulation due to cancer cell death (apoptosis or necrosis) or release from viable cells. Once the genomic DNA of a cancer cell is shed into the blood stream, it is called cell-free DNA (cfDNA). This cfDNA retains the DNA methylation pattern of the cancer cell from which is was shed.

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. In particular, the DNA base cytosine can be methylated at the C-5 position of the cytosine ring (5-methylcytosine, 5-mC). 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.

 
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 genomic DNA of cancer cells is shed into circulation due to cancer cell death (apoptosis or necrosis) or release from viable cells. Once the genomic DNA of a cancer cell is shed into the blood stream, it is called cell-free DNA (cfDNA). This cfDNA retains the DNA methylation pattern of the cancer cell from which is was shed.
 
An IvyGene Score of 1-19 is considered normal. An IvyGene Score of 20 or greater is considered elevated.
 
The sensitivity of the IvyGene Cancer Blood Test is approximately 84% and Specificity of the IvyGene test is approximately 90%. The sensitivity of the IvyGene Cancer Blood Test detects additional cancer types is being investigated.
 
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.
 

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.
 
For more information about the Ivygene Blood Cancer Test you can call us at (844) 489-4363 or Send us an email directly.

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