Huningue, France – July 22, 2025 – Firalis SA is pleased to announce the official launch of clinical activities for its Healthy Volunteer Clinical Study (HVCS), following the First Patient First Visit (FPFV) on June 18, 2025.
This milestone follows a favorable opinion from the Comité de Protection des Personnes (CPP) and the approval request by the Agence nationale de sécurité du médicament et des produits de santé (ANSM).
Study Overview
- Study Title: Clinical study on healthy volunteers for validating the stability of different diagnostic biomarkers studied at Firalis
- Study Code: ST0214
- Clinicaltrial.gov: NCT05160337 Study Details | Validation of the Stability of Diagnostic Biomarkers on Healthy Volunteers | ClinicalTrials.gov
- RCB Number: 2021-A00405-36
- CPP ID: 1-21-029 / ID 11650
- ANSM Dossier Number: 21.02.26.71457
- Sponsor: Firalis SA
- Principal Investigator: Prof. Dr. Pierre Rohrlich, MD, PhD
- Design: Prospective, monocentric, non-randomized
- Participants: 60 healthy volunteers (expanded from 48), aged 18 to 85
- Study Duration: Extended to April 1, 2027
Study Objectives
The primary objective of the HVCS study is to evaluate the stability of diagnostic biomarkers—including lncRNA, sncRNA, mRNA, proteins, and lipids/metabolites—across various biological fluids (blood, urine, saliva, buccal cells) under differing demographic and lifestyle conditions.
Secondary objectives include assessing the reproducibility of biomarker measurements across different timepoints, operators, and assay platforms.
Visit Schedule
Each participant is scheduled for two study visits:
- Visit 1 (Day 1): Screening and initial biological sampling
- Visit 2 (Month 3 ±15 days): Follow-up biological sampling
Sample Collection & Processing Sites
- Centre de Prélèvement Biologique de Firalis
7 Allée des Marronniers, 68330 Huningue, France
Clinical visit and sample collection site
- Firalis Headquarters
17 Rue du Fort, 68330 Huningue, France
Administrative and R&D center
- Firalis Biobank & Analytical Platforms
35 Rue du Fort, 68330 Huningue, France
Dedicated to sample processing, QC, storage, and analysis
Commitment to Innovation
This study reinforces Firalis’ long-standing mission to develop innovative in vitro diagnostic (IVD) tools aimed at early detection and patient stratification, especially in critical areas such as cardiovascular and neurodegenerative diseases. It highlights Firalis’ dedication to advancing precision medicine through rigorous clinical research and biomarker validation.
The study samples and associated clinical and biological data can be used for third party projects, and collaboration with public and private institutions developing new biomarkers for research and candidate IVD kits for clinics.
For more information, please contact:
📧 clinical@firalis.com