thrombomiR™ microRNA qPCR test kit

TAmiRNA’s new thrombomiRTM microRNA qPCR kit provides a novel but easy to use tool for analyzing platelet-function using circulating plasma miRNAs. The kit enables standardized analysis of platelet-derived microRNA to determine platelet function in vivo.

Tests using thrombomiRTM microRNA qPCR require only 200 μL of fresh or frozen plasma, which means they can be minimally invasive.

The kit is based on a simple technology platform and can be rapidly implemented in genetic test laboratories. It is particularly useful for clinical research groups and pharmaceutical companies that are active in platelet function research, anti-platelet therapy and age-related/cardiovascular diseases worldwide.

Background

Platelets contain miRNAs and the expression profiles within platelets correlate with platelet activity. During activation platelets release microparticles containing miRNAs that might be taken up by other cells, allowing direct regulation of the recipient cell´s mRNA profile and gene expression. Therefore circulating miRNA, plasma and serum miRNA profiles may find use in clinical practice as novel biomarkers and markers of prognosis and treatment response.

Platelets play a key role in hemostasis, initiating and propagating thrombosis. Dysregulation and inappropriate activation of platelets occurs in a wide range of serious age-associated diseases, including stroke and myocardial infraction. Precise knowledge of the platelet status of a patient is also critical in clinical decision making, since impairment of platelet functions can result in bleeding disorders and additional risk during surgery.

There are three principal advantages in using quantitative analysis of circulating miRNAs in human plasma as a novel and important measure of platelet function.

• First, the miRNA circulation reflects a platelet function that is independent of any specific activation pathway
• Second, the test reflects the in-vivo function of platelets for more representative results
• Third, results can be measured using deep-frozen samples. This simplifies administration with less need for invasive taking of blood samples from patients to assess bleeding risk and response to therapeutic platelet inhibition

These help to explain why use of plasma microRNAs as in vivo biomarkers of platelet function has matured to become one of the first validated diagnostic applications of this technology.

The thrombomiRTM kit’s development originated from an academic research project conducted at the laboratory of Dr. Manuel Mayr at the King´s British Heart Foundation Centre, King´s College London, UK, which produced a blood-based biomarker signature as a novel measure of platelet function.

Features

The thrombomiRTM workflow is intended or research-use as an outcome in observational or interventional clinical trials. It is particularly useful for pharmaceutical companies and clinical research groups, which are active in platelet function research and development.

The kit enables simple and rapid analysis of thrombomiRs, which are circulating microRNAs that reflect platelet function. ThrombomiRs enable personalized monitoring of anti-platelet therapy, and the assessment of bleeding-risk due to impaired platelet activation. Since platelet function is an important contributor to cardiovascular disease, utility for bleeding risk due to traumatic events, risk assessment of adverse cardiovascular events and early diagnosis of type-2 diabetes have been proposed.

The qPCR kit is designed to enable easy, standardized, and robust analysis of platelet-derived microRNAs in plasma. This analysis is simplified through the implementation of a software solution with a user-friendly interface.

The thrombomiR workflow is a novel platelet-function test, with minimal invasive needs requiring just 200µl of plasma. Retrospective analysis using frozen samples is possible.

The kit also uses an innovative workflow in which standardized circulating microRNA is analyzed by offering a set of control assays and a proprietary normalization strategy. This result is an in vivo measure of platelet function that is independent of the activation pathway.

Benefits

The thrombomiRTM qPCR kit provides a clear alternative to commonly-used platelet function tests such as LTA, VerifyNow® or PFA-100®, which all need fresh blood and agonists and further exhibit clear lack of standardization with an analytical variability that may induce misinterpretations.

Key advantages are that the thrombomiRTM microRNA qPCR test generates a reliable measure of platelet function and only requires 200 μL of fresh or frozen plasma. It is based on a simple technology platform, which makes it easy to implement the test in genetic test laboratories.

The thrombomiRTM qPCR kit thus delivers a clear set of user benefits. These include:

– More rapid test results
– Minimal invasiveness
– Easy, standardized workflow for circulating microRNA analysis
– Sophisticated panel of controls to generate high quality data
– High sensitivity and specificity
– Comparability of data due to standardized data processing and normalization

The kit provides and easy and cost-efficient solution for analysis of platelet function that makes this test accessible to laboratories and clinics lacking facilities for point-of-care testing.

There are minimal regulatory requirements since the qPCR kit is intended for research purposes only, which includes clinical research and secondary outcome of clinical trials.

A further testing product for cardiometabolic diseases is already in TAmiRNA’s research and development pipeline.

Resources

Click on thrombomiR specifications for product information.