Trials / Completed
CompletedNCT06432192
A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis
ApoDiag: A Prospective, Monocentric Clinical Study for the Validation of in Vitro Diagnostic Tests Developed by Firalis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,474 (actual)
- Sponsor
- Firalis SA · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | APO-Easy | Testing for the APOE genotype using the APO-Easy Genotyping test |
Timeline
- Start date
- 2024-01-02
- Primary completion
- 2025-03-25
- Completion
- 2025-03-25
- First posted
- 2024-05-29
- Last updated
- 2025-04-30
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT06432192. Inclusion in this directory is not an endorsement.