A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis

Firalis SA1,474 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,474

Conditions

Genetic Health Risks

Interventions

APO-EasyDIAGNOSTIC_TEST

Testing for the APOE genotype using the APO-Easy Genotyping test

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Donors who sign the informed consent forms for sample collection and for genotyping. * Adults, both genders, aged 18-85 years. * Not under any administrative or legal supervision Exclusion Criteria: * Anyone who did not sign the Informed Consent form. * Subjects aged below 18 years and older than 85 years are excluded. * Pregnant, parturient and nursing women are excluded

Outcomes

Primary Outcomes

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

Secondary Outcomes

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