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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APOE E | The cohort will be genotyped to determine the phenotype of the APOE allele |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APO-Easy | Diagnostic Test | Testing for the APOE genotype using the APO-Easy Genotyping test |
|
| Measure | Description | Time Frame |
|---|---|---|
| APOE Genotype | 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 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Specimen stability | Blood samples will be collected to establish the stability of PAXgene DNA samples at different timepoints after storage at -20° and -80°C. | Baseline, 24hrs, 5 days, 28 days, 3 months, 12 months, 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy donors
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| Name | Affiliation | Role |
|---|---|---|
| Huseyin Firat, MD PhD | Firalis SA | Study Director |
| Lucas Pham-Van, PhD | Firalis SA | Study Chair |
| Joanna Michel | Firalis SA | Study Chair |
| Sthepanie Boutillier, PhD | Firalis SA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EFS GEST | Nancy | 54100 | France | |||
| EFS GEST |
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| ID | Term |
|---|---|
| D019636 | Neurodegenerative Diseases |
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| Strasbourg |
| 67000 |
| France |
| D001523 | Mental Disorders |
| D024801 | Tauopathies |