pipeline

cell-free RNA biomarker discovery and development platform

TAmiRNA operates a fully equipped biosafety level 2 R&D laboratory for automated, sequencing-based screening of microRNAs, mRNAs and other short and long non-coding RNAs. With highly sensitive workflows such as miND® and SMART-Seq®, we quantify RNA in virtually any biological sample: cells, tissues, biofluids and extracellular vesicles (EVs). We have implemented and benchmarked several protocols for isolating EVs from biofluids and cell culture supernatants, and we validate biomarker candidates by locked nucleic acid (LNA) and SYBR® Green-based RT-qPCR. Machine-learning methods allow us to test biomarker combinations and build multivariable algorithms that outperform single markers.

More than 13 years of biomarker development have given us a detailed understanding of the pre-analytical, analytical and biological variability that affects cell-free RNA measurements. Our workflows include dedicated steps to control this variability and improve the signal-to-noise ratio of biomarker candidates.

Once biomarker performance is validated, we design and develop an in vitro diagnostic (IVD) device to quantify the biomarkers, together with software for data analysis and interpretation. Both follow controlled processes under our ISO 13485-certified quality management system and meet the requirements of the In Vitro Diagnostic Regulation (IVDR, EU 2017/746). Performance evaluation studies covering scientific validity, analytical and clinical performance complete the technical documentation of each new device.

To study the biological function and mechanism of new microRNA biomarkers, we use molecular tools, in vitro bioassays and in vivo models developed with the Grillari Labs, the Ludwig Boltzmann Institute, Evercyte and the TELL research group at the Medical University of Vienna.

biomarker development programs

TAmiRNA uses cell-free microRNAs as biomarkers for diagnosis, prognosis of disease outcome, and monitoring of disease progression or treatment response. Our goal is to develop biomarker-based decision-support tools that improve patient management, from acute and critical care to chronic and age-related disease. Our pipeline currently comprises six programs:

hepatomiR®: a CE-marked and commercially available in vitro diagnostic test that stratifies patients with primary or metastatic liver cancer by their risk of post-hepatectomy liver failure. Find out more about hepatomiR® here.

promiR®: a validated microRNA signature in synovial fluid with excellent performance for diagnosing periprosthetic joint infection. The signature is now being developed into an IVD test. Read more about promiR® in this publication.

toxomiR®: a panel of highly tissue-specific microRNAs for sensitive and specific detection of drug-induced organ injury, organ toxicity and acute tissue damage. Find out more about toxomiR® here.

senomiR®: a microRNA signature identified in senescent cells, with potential for minimally invasive monitoring of senescence burden, biological age and response to interventions such as senolytic therapy. Read more about senomiR® in this preprint.

thrombomiR®: microRNAs that are highly enriched in platelets. Platelet activation raises and antiplatelet therapy lowers their plasma levels, which can be measured with the thrombomiR® RUO kit. Find out more about thrombomiR® here.

osteomiR®: circulating microRNAs that have repeatedly been linked to bone disease and fracture, applied to fracture risk assessment in postmenopausal women. The osteomiR® RUO kit quantifies this panel in serum or plasma. Find out more about osteomiR® here.