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Clinical Trial Summary

Stability studies on the peripheral biomarkers (lncRNAs, sncRNAs, mRNAs, proteins, lipids/metabolites) measured by Firalis IVD test candidates and effect of gender, age, nutrition on their expression level


Clinical Trial Description

Firalis SA and its affiliate Amoneta Diagnostics SAS are developing novel in-vitro diagnostic (IVD) tests for diverse diagnostic applications for major human diseases, including cardiovascular, and neurodegenerative disorders. These tests measure in blood and other peripheral body fluids; long non-coding RNAs (lncRNAs), small non-coding RNAs (sncRNAs), messenger RNAs (mRNAs), circulating proteins, lipids and metabolites. In addition, since 2020, Firalis is producing the salivary test EasyCOV for detection of Covid-19 positivity in both symptomatic and asymptomatic subjects. Firalis group is the sponsor of a pipeline of various clinical studies conducted in diverse National and European clinical sites of excellence, enrolling patients affected by the targeted diseases studied such as acute myocardial injury, Alzheimer disease for the proof of performance phase of the biomarkers and IVD test candidates. The present specific study aims to collect biological samples to complete the analytical validation of its diverse IVD tools namely the evaluation of the stability of the biomarkers and the effect of age, gender, nutrition and inter-period on the expression level of the studied biomarkers. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05160337
Study type Interventional
Source Firalis SA
Contact Rodwell Mkhwananzi, LD
Phone 0389911320
Email rodwell.mkhwananzi@firalis.com
Status Not yet recruiting
Phase N/A
Start date August 2024
Completion date August 2026

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