US Biomarkers has an unrivaled and proprietary technology for DNA methylation discovery in ULTRA-SMALL samples. This technology opens unprecedented opportunity for discovery of biomarkers in any type of clinical samples through genome-wide testing of DNA methylation in every fragment of DNA regardless of the sample type or size. While cell-free circulating DNA from blood is our favorite, other samples have been successfully tested by our technology.

This technology (MethDet®) is built on selective destruction of unmethylated fragments by a methylation-sensitive restriction enzyme and detection of surviving fragments (Schema of MethDet).

With MethDet we can analyze DNA methylation on a genome-wide scale using ultra-small samples (less than 1 ng or less than 200 cells), which are too small for other competing technologies. MethDet® works with multiple types of samples including fresh-frozen or formalin-fixed and paraffin-embedded (FFPE) tissues, laser-capture microdissected (LCM) tissues, circulating tumor cells (CTC), fine needle biopsies (FNA) and cell-free circulating DNA (cfDNA) from blood. Each specimen reveals its DNA methylation secrets when MethDet® is used.

MethDet® takes advantage of microarrays to find the best biomarker candidates, either among all CpG islands (244,000 CpG island array) or in the whole genome using a tiling array (>45 million probes with 35 bp resolution). The best candidates are selected and then confirmed by quantitative PCR, and arranged into signature biomarkers of 8-12 individual DNA fragments. The resultant clinical-grade assay is based on qPCR with the DNA fragments of the signature biomarker.

DNA methylation reflects gene expression, so the MethDet® is useful anywhere gene expression plays a role:

  • Screening and Differential diagnostics: Since gene expression is different in cancer, inflammatory, benign, neurodegenerative, psychiatric and other diseases, these conditions can be detected early by the MethDet®;
  • Companion Diagnostics (CDx): With gene expression also indicative of a patient's sensitivity (or resistance!) to drugs, the MethDet® will provide companion diagnostic biomarkers to select the most effective and the least harmful drugs for a patient facilitating development of personalized medicine;
  • Prognosis: Prognostic and monitoring biomarkers that determine the risk of recurrence and identify it early can be readily developed using MethDet®.
schema of MethDetFigB7 3paneltechnology overview graph
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