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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
Biomarker based IVD tests
Firalis Clinical Investigation Center
Huningue, France
RECRUITINGlncRNA Biomarker expression before breakfast intake
lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples
Time frame: T0- Baseline in the morning before breakfast at fasting conditions
lncRNA Biomarker expression after breakfast intake
lncRNA expression in count per million measured in blood plasma and whole blood paxgene samples
Time frame: T1- 1 hour after breakfast
sncRNA Biomarker expression before breakfast intake
sncRNA cycle threshold measured in blood plasma
Time frame: T0- Baseline in the morning before breakfast at fasting conditions
sncRNA Biomarker expression after breakfast intake
sncRNA cycle threshold measured in blood plasma
Time frame: T1- 1 hour after breakfast
mRNAs Biomarker expression before breakfast intake
mRNAs cycle threshold measured in blood plasma
Time frame: T0- Baseline in the morning before breakfast at fasting conditions
mRNAs Biomarker expression after breakfast intake
mRNAs cycle threshold measured in blood plasma
Time frame: T1- 1 hour after breakfast
Soluble proteins Biomarker expression before breakfast intake
Soluble proteins expression in ng/mL measured in blood plasma
Time frame: T0- Baseline in the morning before breakfast at fasting conditions
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Soluble proteins Biomarker expression after breakfast intake
Soluble proteins expression in ng/mL measured in blood plasma
Time frame: T1- 1 hour after breakfast