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

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.

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