TAmiRNA is responsible for establishing an NGS-based pipeline for discovery of novel potential biomarkers in clinical samples within the TransBioLine consortium. Specifically, TAmiRNA’s responsibilities include:

1. Leading the work package on microRNA biomarker discovery, validation and qualification.
2. Implementing and validating an NGS platform for absolute quantification of microRNAs in different biofluids including serum, plasma, and CSF.
3. Application of this platform for comprehensive characterization of the human circulating miRNome in normal healthy volunteers and patients with drug-induced organ injuries.
4. Development of sensitive and specific organ injury miRNA signatures for kidney, liver, pancreas, vascular and CNS under compliance with regulatory requirements.

TransBioLine brings together scientists and clinicians to facilitate the development and implementation of novel safety biomarkers in clinical trials and the diagnosis of disease. This goal complements the core competence of TAmiRNA, which specializes in the discovery and validation of microRNA biomarkers.

MicroRNAs are small non-coding RNAs that regulate gene expression in human cells. These molecules are produced by virtually all cell types, and their expression can be affected by various physiological stimuli and pathological processes. Taking advantage of the fact that microRNAs can be measured in both tissues and liquid biopsies, including plasma, serum, and cerebrospinal fluid, and that their expression profiles differ between healthy and diseased individuals, TAmiRNA developed a microRNA Next-Generation Sequencing Discovery Assay (miND®) for genome-scale analysis and absolute quantitation of circulating microRNA biomarkers.

TransBioLine enabled us to develop and validate a microRNA Next-Generation Sequencing Discovery Assay (miND®) and provided a unique opportunity to perform comprehensive NGS profiling of microRNA expression across hundreds of patients with various organ injuries as well as normal healthy volunteers. This allowed us to generate a unique dataset ensuring the opportunity to perform direct comparisons and identify differences between the absolute concentrations of microRNAs across different biofluids (plasma, serum, cerebrospinal fluid) as well as various diseases.

TAmiRNA served as a reliable partner in executing the analysis of microRNA biomarkers as well as acting as a leader for the work package on microRNA biomarker discovery, validation and qualification. We spearheaded the publication of two research papers in peer-reviewed journals, describing the unique proprietary miND® pipeline and are continuing our work on the data generation and analysis within various organ work packages:

1. Khamina K, Diendorfer AB, Skalicky S, Weigl M, Pultar M, Krammer TL, Fournier CA, Schofield AL, Otto C, Smith AT, Buchtele N, Schoergenhofer C, Jilma B, Frank BJH, Hofstaetter JG, Grillari R, Grillari J, Ruprecht K, Goldring CE, Rehrauer H, Glaab WE, Hackl M. A MicroRNA Next-Generation-Sequencing Discovery Assay (miND) for Genome-Scale Analysis and Absolute Quantitation of Circulating MicroRNA Biomarkers. Int J Mol Sci. 2022 Jan 22;23(3):1226. doi: 10.3390/ijms23031226. PMID: 35163149; PMCID: PMC8835905.
2. Diendorfer A, Khamina K, Pultar M and Hackl M. miND (miRNA NGS Discovery pipeline): a small RNA-seq analysis pipeline and report generator for microRNA biomarker discovery studies [version 1; peer review: 2 approved with reservations]. F1000Research 2022, 11:233

TransBioLine will provide comprehensive information on the set of potential biomarkers, including microRNAs, that can reliably detect injuries of various organ systems. In the future these biomarkers will help to increase patient safety by enabling early diagnosis of tissue damage, patient stratification and taking informed decisions on the treatment. On the other hand, TransBioLine has resulted in the generation of important tools that can improve the standards of biomarker discovery procedures. For example, the miND® spike-in and bioinformatics pipeline that were originally developed for the TransBioLine project enable quality control and absolute quantitation of microRNAs across different sample types and conditions, becoming an important product that is currently offered by TAmiRNA:
https://www.tamirna.com/mind-spike-ins/

Furthermore, TransBioLine led to the establishment of the network among industrial, academic partners as well as small and medium enterprises, which generated invaluable comprehensive datasets across different diseases and normal healthy volunteers.

It was an exciting opportunity to work side-by-side with leading experts from various fields on the problem that has a direct impact on the lives of patients. I am thrilled to see the results from the TransBioLine project being published and becoming available to the scientific community.