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

Completed

• Conditions: Genetic Health Risks
• Interventions: Diagnostic Test: APO-Easy

• Registration Number: NCT06432192
• Lead Sponsor: Firalis SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-02
• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-05-22
• Study First Posted: 2024-05-29
• Status Verified: 2024-09
• Primary Completion: 2025-03-25
• Study Completion: 2025-03-25
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1474

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
APOE E	APO-Easy	The cohort will be genotyped to determine the phenotype of the APOE allele

Primary Outcome Measures

Name	Time	Method
APOE Genotype	Baseline	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

Secondary Outcome Measures

Name	Time	Method
Specimen stability	Baseline, 24hrs, 5 days, 28 days, 3 months, 12 months, 24 months	Blood samples will be collected to establish the stability of PAXgene DNA samples at different timepoints after storage at -20° and -80°C.

Trial Locations

Locations (1)

EFS GEST; 🇫🇷 Strasbourg, France