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

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.

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Key information

Conditions

Genetic Health Risks Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

EFS GEST, Nancy, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APO-Easy

Diagnostic Test

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

Primary outcomes

APOE Genotype

Time frame: 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 outcomes

Specimen stability

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Firalis SA

Industry

Registry information

Official study title

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

Acronym: ApoDiag

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: May 29, 2024
Registry last updated: Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed