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

Firalis

Status: Enrolling

Conditions: Genetic Health Risks

Treatments: Diagnostic Test: APO-Easy

Study type: Observational

Funder types: Industry

Identifiers

NCT06432192

2023-A02120-45

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

600 participants in 1 patient group

APOE E

Description:

The cohort will be genotyped to determine the phenotype of the APOE allele

Treatment:

Diagnostic Test: APO-Easy