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    TAmiRNA GmbH

    Overview

    TAmiRNA GmbH is a biotech company and contract research organization (CRO) that specializes in identifying and validating non-coding RNAs as biomarkers enabling ‘precision medicines’ for age-related diseases. The mission of TAmiRNA is to provide validated diagnostic solutions to patients with serious aging-related illnesses, aiming to improve and prolong patient stability, health and quality of life with increasing age.

    TAmiRNA is actively involved in R&D projects in osteoporosis (OP) and cardiovascular disease (CVD), liver disease and aging: multi-factorial illnesses in which different tissues and cellular processes are involved in onset and progression. Using microRNA signatures, TAmiRNA aims to decode the contributing disease factors at a personalized level, applying this knowledge to better diagnosis.

    Technologies

    TAmiRNA specializes in technologies for profiling levels of blood-circulating microRNAs and developing multi-parametric classification algorithms (“signatures”). TAmiRNA uses these technologies to develop minimal-invasive diagnostic tests for early diagnosis and prognosis of disease, or as companion diagnostic tests to support treatment decisions.

    TAmiRNA’s technologies are based on research observations that so-called “circulating microRNAs” are secreted from cells and freely floating blood, where they are protected from degradation by vesicular encapsulation.

    Subject of numerous IP filings between 2010 and 2023, TAmiRNA’s core proprietary technologies relate to:

    • A miRNA panel for identification of patients with high risk of postoperative liver dysfunction
    • A microRNA panel for diagnosis and treatment of bone disorders such as osteoporosis
    • MicroRNA-31 for diagnosis and treatment of bone and cardiovascular disorders
    • A microRNA panel for the analysis of platelet activation in patients that can be used to monitor efficacy of anti-platelet therapies

    Products and Services

    TAmiRNA uses its technology for the discovery and validation of circulating microRNAs as biomarkers for age-related diseases. The pipeline includes developments in osteoporosis, cardiovascular disease, type-2 diabetes, liver and cancer.

    These biomarkers have been selected based on their utility for early diagnosis or prognosis of disease, and can be used to identify stratified patient subgroups that share similar disease profiles and therefore medical needs.

    TAmiRNA microRNA qPCR kits and software solutions enable users to quantify the levels of specific microRNA combinations in serum, plasma, urine or other biofluids.

    Products

    During 2016, TAmiRNA rolled out its first products, the osteomiR® ‘research use only’ kit for bone quality and fracture risk, followed by the thrombomiR® microRNA qPCR test kit for platelet function.In 2022, TAmiRNA was granted CE-IVD certification for its miRNA liver biomarker panel hepatomiR®.

    • hepatomiR® is a signature of plasma miRNAs in patients with high risk of postoperative liver dysfunction. Others currently investigated intended uses of the product are the assessment of liver function in the context of acute or chronic liver diseases.
    • osteomiR® is a signature of serum microRNAs associated with bone quality. The osteomiR microRNA signature is intended to assess the risk of a first fracture in postmenopausal and type-2 diabetic women independent of BMD. This information enables timely interventions and can help to avoid fractures.
    • thrombomiR® is a signature of plasma microRNAs associated with platelet function pathway independent. The thrombomiR signature is intended to assess treatment response to anti-platelet therapy and bleeding risk. This information helps to identify drug-resistant patients, optimize drug dosage and drug efficacy while reducing the risk of bleeding.

    Next to miRNA biomarker panels, TAmiRNA expertise in miRNA NGS analysis led to development and release of the miND Spike-Ins® in 2022. The miND Spike-Ins® are a proprietary oligonucleotide mix with unique design features that enable quality control and absolute quantification of miRNAs in small RNA-sequencing experiments.

    Services

    TAmiRNA offers contract research services for companies in need of targeted CDx biomarker development. It collaborates with (bio)pharma companies with drug development programs in human and veterinary medicine, medtech companies and clinical research groups to generate tailored biomarker solutions.

    TAmiRNA supports its clients by providing one-stop-shop solutions for biomarker development and industrialization, including the discovery, validation and industrialization of biomarker candidates.

    TAmiRNA has also implemented a wide range of analytical and technology services for analysis of coding and non-coding RNAs including transcriptomic analyses such as quantitative PCR, digital PCR, microarray, and next generation sequencing as well as cell-based assays for deciphering microRNA function.

    Furthermore, TAmiRNA has developed workflows for analysis of most challenging sample types, such as extracellular vesicles (EVs) and microdissected tissues. Multiomics analysis enabled by TAmiRNAs partners completes the services portfolio.

    Structure and background

    TAmiRNA is a privately owned company, headquartered in Vienna. Its founders, Matthias Hackl, Otto Kanzler, Regina Grillari and Johannes Grillari share a strong interest in musculoskeletal disorders, especially osteoporosis, and cardio-vascular disease along with a guiding vision “to bring more life into the age of human”.

    TAmiRNA was founded in November 2013 with pre-seed funding attracted the previous summer. Further seed funding arrived a year later, hard on the heels of an investigator award from the American Society for Bone and Mineral Research (ASBMR) and the European Calcified Tissue Society (ECTS).

    In May 2015, TAmiRNA was runner-up in the Best of Biotech International Awards. Later that year, the company received Phase 1 funding for its SME instrument and was also named HighTec winner in the GEWINN Young Entrepreneur Awards.

    Standards and Compliance

    TAmiRNA has implemented a Quality Management System according to ISO 9000/9001 guidelines and has selected OEM equipment manufacturing partners that are ISO 13485 certified, allowing it to supply products that are CE-compliant.

    During 2014, TAmiRNA acquired Exiqon A/S “Center of Excellence” status with all quality ad compliance aspects regularly assessed by internal and external audits.

    2022 TAmiRNA has received ISO 13485:2016 certification for its Medical Device and Quality Management System.

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