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

NCT06432192 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1474

Last updated 2025-04-30

No results posted yet for this study

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

  • Genetic Health Risks

Interventions

DIAGNOSTIC_TEST

APO-Easy

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

Sponsors & Collaborators

  • Firalis SA

    lead INDUSTRY

Principal Investigators

  • Huseyin Firat, MD PhD · Firalis SA

  • Lucas Pham-Van, PhD · Firalis SA

  • Joanna Michel · Firalis SA

  • Sthepanie Boutillier, PhD · Firalis SA

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2025-03-25
Completion
2025-03-25

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06432192 on ClinicalTrials.gov