Mi-Test Initiative


What is "Mi-Test"

Currently, there are several thousands of original research reports demonstrating the potential of cell-free microRNAs, and other circulating RNA biotypes, as non-invasive biomarker candidates for diagnostic, prognostic, and predictive applications. However, there are still no officially approved diagnostic tools based on extracellular miRNA signatures to be used on human subjects. In addition, there are multiple inconsistencies and significant variations among the reported microRNA biomarker signatures. Finally, the detection of extracellular RNA is generally associated with substantial technical and analytical challenges due to its low concentration in biological fluids.

Heidelberg Biolabs has developed a spectrum of products to leverage the full potential of circulating RNAs to mirror the health status of the human body. Predicting the ongoing pathological processes in specific organs could immensely improve the management of age-associated disorders such as metabolic syndrome, fatty liver, diabetes, stroke, myocardial infarction, and various cancers. Primarily, we apply highly sensitive qPCR assays for detecting extracellular circulating microRNAs that are uniquely expressed in certain organs and tissues. One of our major goals is to establish a framework for preventive diagnostics of these disorders using extracellular circulating miRNA biomarkers. We propose that such measurement of organ-specific miRNAs (along with other circulating RNA species) can be performed in a separate blood test ("Mi-Test") at point-of-care stations along with conventional blood tests. The current version of "Mi-Test" consists of several miRNAs expressed exclusively in the myocardial cells and whose presence in the blood plasma, therefore, is indicative of the ongoing cell death in the myocardium. The future versions of the test are planned to include other microRNAs - indicators of ongoing pathological processed with the sensitivity and specificity exceeding ordinary blood tests.

The above figure (adapted from Turchinovich et al, 2018) outlines the putative logistics of a population-wide blood-based biomarkers examination. The blood samples collected initially at point-of-care stations upon first appointments with patients are transported to the central lab where they are analyzed for the presence of related soluble nucleic acids biomarkers such as myocard-specific microRNAs. After receiving the initial blood test results, the corresponding patients might be recommended to undergo further (more complex) tests including an electrocardiogram.


"Mi-Test" has not been yet cleared, approved or authorized by FDA or any other organization for the diagnostic use, or the use by authorized laboratories to conduct diagnostic procedures. However, Heidelberg Biolabs GmbH aims to pursue the required steps for "Mi-Test" (and similar tests based on the circulating nucleic acids biomarkers) to be authorized and approved for diagnostic and prognostic purposes in the future. Nevertheless, the results of Heidelberg Biolabs "Mi-Test" can serve as a recommendation to conduct a visit to a health care professional.

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