Science

DiaPat®: Biomarkers of unique accuracy

The DiaPat® technology is based on the knowledge that pathological changes in the human body show up very early in the protein composition of the body fluids. This knowledge has long been used worldwide for clinical diagnostics. The method enables the analysis of hundreds of proteins in a single analytical step.

Novel: Coupling of capillary electrophoresis with mass spectrometry

The technology is based on the novel coupling of two established measuring methods: capillary electrophoresis (CE) and mass spectrometry (MS). The proteins are first separated by capillary electrophoresis in an electrical voltage field and then measured in a mass spectrometer. The CE-MS coupling technology has been accepted by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

Analytical precision: Reproducibility of protein pattern recognition

An important criterion here is the reproducibility of protein pattern recognition. The analytical precision of the sample measurement on different measuring instruments and at different locations was investigated in this context and presented to the regulatory authorities. The biomarker patterns exhibit an excellent accuracy that was previously not considered possible.

The data obtained, which are approximately 1 gigabyte in size, are evaluated by means of special software and compared with the disease-specific protein patterns in the DiaPat® database. Based on the proteins found, the test result can then be generated.

From a single urine sample, the data volume of about 1 gigabyte is obtained.

DiaPat® protein pattern database (please click to enlarge)

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