The Science

Our Platform

LAM’s platform is based on cell-free DNA (cfDNA) methylation detection. Using Next Generation Sequencing combined with our proprietary discoveries of specific gene targets that correlate with cancer presence, the company is turning peer reviewed science into products available today, starting with our IvyGene test.

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.

Biobank and Sequencing

LAM’s extensive biobank of patient blood samples enables us faster discovery of critical markers to create screening tests for other cancer types. Our biobank samples include the following data:  whether the patient had cancer or not, type and severity of the cancer, treatments administered, pathology report, sex, age.

LAM has sequenced over 100,000 patient’s blood samples. These patients were clinically confirmed for positive/negative cancer at the time of blood draw. LAM has published some of these results in the Proceedings of National Academy of Sciences (for liver, lung, breast and colorectal cancers) and Nature Materials (for liver cancer). Additional studies have been drafted and submitted to top journals such as Cell and Nature. LAM has scanned over a million methylation positions (CpG islands) for correlation to clinically confirmed cancer. The total data analyzed by LAM is to the order of tens of millions of GBs. Through these millions of methylation positions, LAM has identified and patented primers/probes for thousands of CpG islands which correlate to 23 different cancer types.

The research and discovery were conducted in the United States with validation in China and further validation in the United States.

IvyGene Test

LAM’s first test, IvyGene, is a blood test that uses advanced DNA sequencing methods to detect the DNA methylation pattern of cfDNA in blood samples to detect the presence of cancer and give quantifiable information about the cancer.

It differs from genetic tests that are based on DNA mutations that provide patients only information about their propensity or likelihood for the development of cancer. The IvyGene test is based on DNA methylation which provides confirmation of cancer at the time of testing.

IvyGene will become the company’s platform of blood tests that measures the methylation status of cell-free DNA at target gene sites. These target gene sites have been demonstrated to be hypermethylated when certain cancers are present.

Test results are reported as a quantitative IvyGene Score. 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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Patents

Laboratory for Advanced Medicine currently has one patent issued and nine pending covering the use of the discovered CpG islands for diagnostic use.

Publications