Today we announce that TAmiRNA has received ISO 13485:2016 certification for its Medical Device and Quality Management System after successfully completing the audit through Germany-based notified body MDC. This ISO certification indicates that TAmiRNAs quality management system meets the most current regulatory requirements applicable to the medical device industry. "We are very proud of this certification as it demonstrates the commitment of our team to meet customer and international regulatory expectations," said Matthias Hackl, Co-Founder and CEO of TAmiRNA. ISO 13485:2016 is an internationally recognized quality systems standard tailored to the development and manufacturing of medical devices, including in-vitro diagnostic tests. This certification represents an important milestone for our company, and reflects our rigorous and risk-based approach [...]
- Plasma levels of platelet-enriched microRNAs change during antiplatelet therapy in healthy subjectsbiomarkers, diagnose disease, extracellular vesicle, microRNA, platelet-associated miRNAs, smallRNA, thrombomiR, treatment monitoring
We want to draw your attention to our most recent publication where we investigated platelet-enriched miRNAs (thrombomiRs) as suitable candidates for monitoring antiplatelet therapy. The study provides evidence that thrombomiRs are promising biomarker candidates for monitoring the extent of platelet inhibition. This could enable stratification of patients depending on their response to antiplatelet therapy and guide treatment decisions. click here to read the paper
The collaboration between Biogenity and TAmiRNA is a big step towards further enabling our clients to identify new biomarkers that can be used to diagnose disease, monitor treatment response, and predict patient outcomes. And an important step to advance omics research and bring better healthcare to future generations. click here to read the press release
The sequencing advance allows genome scale analysis of miRNAs and promises a more efficient discovery approach for safety biomarkers, enabling retrospective analysis. Dr. Kseniya Khamina, TAmiRNA research scientist, will deliver a presentation on ‘Next-generation sequencing pipeline for genome-scale analysis of circulating microRNAs as discovery approach for safety biomarkers’ (P338) during the Biomarkers Poster Session on Day Two, CC Exhibit Hall, of the meeting. The poster was co-authored by TAmiRNA and researchers from the Functional Genomics Center Zurich, Eli Lilly and Company and Merck & Co. Take advantage, meet Kseniya and discuss our latest developments and how TAmiRNA's products and services can assist your business or make an appointment NOW!
Early and reliable detection and monitoring of adverse events is essential for improving of patient safety, reducing late attrition of drug candidates, and enhancing understanding of toxic mechanisms. The Translational Safety Biomarker Pipeline (TransBioLine) project will focus on development of biomarkers of injury for liver, kidney, pancreas, vasculature, central nervous system (CNS) and the development of non-invasive microRNA biomarkers using liquid biopsies. The project is coordinated by the University of Zurich with Pfizer as industry lead, and involves 27 partners (pharmaceutical companies, small and medium-sized enterprises, and academic institutions) from ten European countries and the United States of America. With a total budget of € 28 million, the EU and the pharmaceutical companies involved are financing the [...]
TAmiRNA and advanceCOR, a drug developing biotechnology company which focuses on personalized medicine in cardiovascular diseases, receive Eurostars project entitled: ”A novel microRNA-based platelet function biomarker for personalized anti-thrombotic treatment”. The aim of the Eurostars project is to validate the use of the thrombomiR™ kit for management of anti-thrombotic therapies. The thrombomiR™ kit is a minimally invasive blood test that can determine changes in platelets reactivity (for example due to a therapy), based on the quantitative analysis of microRNAs, Specifically, the thrombomiR™ kit allows the targeted detection and quantitation of platelet-specific microRNAs in blood plasma. The concentration of these microRNAs increases in the course of activation of platelets and decreases as a result of therapeutic inactivation. Thus, [...]