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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06432192

Acronym

ApoDiag

Enrollment

1474

Registered

2024-05-29

Start date

2024-01-02

Completion date

2025-03-25

Last updated

2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Genetic Health Risks

Keywords

Polygenic risk, APOE, Apolipoprotein, Neurodegenerative disorders, Dementia, Alzheimer disease, Genetic risks

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.

Interventions

DIAGNOSTIC_TESTAPO-Easy

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026