“Theranostics” means the increasingly close integration of diagnostics and therapy. The aim of theranostics is to enable the right therapy for the right patient at the right time. MicroRNAs are a new class of biomarkers with enormous potential for applications in theranostics. They are short regulatory RNA molecules that are essential for the proper function of cells and tissues. The development of diseases is mostly based on molecular changes in the affected organs, and there is evidence that diseases also manifest in a change in microRNA expression. Although microRNAs are formed intracellularly, a significant portion of the cellular microRNAs are secreted within vesicles (e.g., exosomes) into the cell supernatant. Extracellular vesicles stabilize RNAs and enable minimally-invasive detection of microRNAs in liquid biopsies (sera, plasma, urine). In order to improve sensitivity and specificity of our tests, not individual microRNAs are used as biomarkers for (patho-)physiological processes but so-called "microRNA signatures". The diagnosis is thus derived from the parallel measurement of a previously deliberately selected microRNA combination (= "signature").
The PATH project pursues two major goals: first, an in-depth characterization of pre-analytical and biological factors influencing microRNA variability in liquid biopsies is performed, in order to make informed decisions about pre-analytics, inclusion and exclusion criteria, and target groups for a test procedure. Secondly, two discovery projects investigating the utility of microRNAs as theranostic biomarkers for guiding therapy in liver and age-related diseases will be conducted.
TAmiRNA´s mission is to develop novel diagnostic solutions for unmet clinical needs, and to offer high-quality analytical services in compliance with the high standards required by diagnostics development.
R&D teams at universities, clinical centers, and companies benefit from TAmiRNA´s compelling solutions for the analysis of non-coding RNAs in biofluids, single-cells or microdissected tissue compartments in any research area. In order to strengthen its service portfolio, TAmiRNA and Vivomicx (www.vivomicx.eu) recently joined forces to combine their technologies of high sensitivity qPCR and laser microdissection, which enables the quantitative analysis of cell-type specific RNA expression in complex tissues.
This technique allows to
- Analyze effects of therapeutic interventions on single cells and small groups of similar cells and therefore gain a better understanding of the mode of action.
- Improve the discovery/characterization of lead drug candidates based on their enrichment in specific tissue compartments (e.g. tumor cells).
- Locate drug-target engagement in specific tissue compartments and quantify downstream effects on gene expression level.
- Identify novel biomarkers for patient selection (CDx) as well as diagnosis and monitoring of disease.
The combination of Vivomicx and TAmiRNA´s proprietary protocols is clearly superior to the current standard where only whole tumor material is analyzed, and marks another step on the road to make the drug development process more efficient and therefore less costly.
In-vitro diagnostic products
TAmiRNA’s osteomiR™ RT-qPCR test provides deep insights into bone quality through analysis of a microRNA bone biomarker signature in serum or plasma. TAmiRNA identified 19 bone-related microRNAs in human serum/plasma samples. Each microRNA has been thoroughly characterized regarding its function and contribution to bone disease [1–4]. The osteomiR™ IVD test is intended for diagnosis of high fracture-risk due to osteoporosis, to select patients at high-risk for preventive therapy. The cost-effectiveness of this approach has recently been demonstrated using health economic evaluations .
TAmiRNA has developed the thrombomiR™ RT-qPCR test, which allows to measure platelet-reactivity in-vivo using fresh or frozen plasma samples. A retrospective study conducted in collaboration with Prof. Dr. Manuel Mayr at King ́s College London, demonstrated the utility of the test to detect and quantify the efficacy of two types of anti-platelet therapies. Thus, future applications of the thrombomiR™ RT-qPCR test will be monitoring of treatment response in patients with cardiovascular disease, as well as the selection of patients with low or high platelet-reactivity for therapeutic treatment. Further information about the TAmiRNAs products and services can be found at www.tamirna.com.
 U. Heilmeier, M. Hackl, S. Skalicky, S. Weilner, F. Schroeder, K. Vierlinger, J.M. Patsch, T. Baum, E. Oberbauer, I. Lobach, A.J. Burghardt, A. V Schwartz, J. Grillari, T.M. Link, Serum miRNA Signatures Are Indicative of Skeletal Fractures in Postmenopausal Women With and Without Type 2 Diabetes and Influence Osteogenic and Adipogenic Differentiation of Adipose Tissue–Derived Mesenchymal Stem Cells In Vitro, J. Bone Miner. Res. Mon. xx (2016) 1–20. doi:10.1002/jbmr.2897.
 R. Kocijan, C. Muschitz, E. Geiger, S. Skalicky, A. Baierl, R. Dormann, F. Plachel, X. Feichtinger, P. Heimel, A. Fahrleitner-Pammer, J. Grillari, H. Redl, H. Resch, M. Hackl, Circulating microRNA signatures in patients with idiopathic and postmenopausal osteoporosis and fragility fractures, JCEM. (2016). doi:10.1210/jc.2016-2365.
 X. Feichtinger, C. Muschitz, P. Heimel, A. Baierl, A. Fahrleitner-Pammer, H. Redl, H. Resch, E. Geiger, S. Skalicky, R. Dormann, F. Plachel, P. Pietschmann, J. Grillari, M. Hackl, R. Kocijan, Bone-related Circulating MicroRNAs miR-29b-3p, miR-550a-3p, and miR-324-3p and their Association to Bone Microstructure and Histomorphometry, Sci. Rep. 8 (2018) 1–11. doi:10.1038/s41598-018-22844-2.
 Riikka Mäkitie, M. Hackl, R. Niinimäki, S. Kakko, J. Grillari, O. Mäkitie, Altered MicroRNA Profile in Osteoporosis Caused by Impaired WNT Signaling, JCEM. (2018).
 E. Walter, H. Dellago, J. Grillari, H.P. Dimai, M. Hackl, Cost-utility analysis of fracture risk assessment using microRNAs compared with standard tools and no monitoring in the Austrian female population, Bone. 108 (2018) 44–54. doi:10.1016/j.bone.2017.12.017