An observational study in Genetic Health Risks, sponsored by Firalis SA. Completed at 2 sites in France. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Firalis SA · Observational
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 detect several gene mutations related to the above-mentioned pathologies. The development of IVD tools requires the evaluation of analytical parameters including biomarker stability.
The present specific study therefore aims to collect whole blood samples in PAXgene DNA tubes to complete the analytical validation of IVD tools and the evaluation of the stability of the DNA in PAXgene DNA tubes and the reagents in the IVD tools.
Healthy donors
Exclusion Criteria:
The cohort will be genotyped to determine the phenotype of the APOE allele
Diagnostic Test: APO-Easy
Testing for the APOE genotype using the APO-Easy Genotyping test
APOE Genotype
Blood samples will be collected to establish the feasibility of detecting several gene mutations associated with the risk of Alzheimer's disease/ Cardiovascular disorder and validation of analytical parameters
Time frame: Baseline
Specimen stability
Blood samples will be collected to establish the stability of PAXgene DNA samples at different timepoints after storage at -20° and -80°C.
Time frame: Baseline, 24hrs, 5 days, 28 days, 3 months, 12 months, 24 months
Plan to share: Undecided
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Firalis SA