Recently Epigene LLC has finished R&D on the epigenetic tests for the early-stage detection of lung, breast and stomach cancer.
In the tests we analyze DNA isolated from the vein blood and use a standard real-time PCR machine.
We are planning to launch the clinical trials and registration in Russia soon
During R&D stage we achieved more than 90% sensitivity and specificity of the tests.
Research was supported by Ministry of Science and Education of the Russian Federation and Skolkovo Foundation.
What is special in our tests and our approach?
We determine DNA methylation markers, but our DNA methylation assay is absolutely new.
Assay is based on a new type of enzymes, recently developed by SibEnzyme – methyl-directed DNA endonucleases or MD DNA endonucleases. MD endonucleases work like traditional restriction enzymes, but, on the contrary, they cut only methylated DNA and may be used in epigenetic studies. More details
GLAD-PCR assay – is a simple and inexpensive method for epigenetic studies of DNA preparations from clinical samples. It allows to detect even several DNA molecules with R(5mC)GY site of interest in a presence of excessive amount of unmethylated DNA. Just 3 easy steps in one tube. More details
Genomic DNA fragmentation with GlaI and subsequent NGS allow to construct a map of R(5mC)GY sites in analyzed genomes of patients and healthy donors. Comparison of these maps reveals R(5mC)GY sites – potential epigenetic markers that can be used for diagnostics. More details
Light fraction of the blood cells is a good source of DNA for our PCR tests. It’s easy to prepare this fraction – one standard table centrifuge, no reagents except saline and minimal time of manipulation with a blood. More details