Study · Completed
Before a test can be trusted,
it has to be tested.
ApoDiag ran for 15 months at two Établissement français du sang (EFS) sites in the Grand Est.
Its purpose was not to discover something new. It was to prove that APO-Easy® performs as specified — and to establish how well DNA samples remain stable and readable after long-term storage.
- Sponsor
- Firalis SAS — Huningue, France
- Registration
- NCT06432192
- Design
- Prospective observational cohort
- Population
- 1,474 healthy blood donors
- Study period
- 2 January 2024 – 25 March 2025
What it set out to measure
Two questions. Defined before the study began.
A validation study is judged against what it set out to measure from the start.
ApoDiag had two predefined objectives:
01 APOE genotype
Can APO-Easy® reliably detect the APOE variants associated with Alzheimer’s disease and cardiovascular risk, and meet its predefined analytical performance requirements?
Primary endpoint · Baseline02 Specimen stability
How stable are PAXgene DNA samples after storage at −20 °C and −80 °C?
Secondary endpoint · Baseline to 24 months
1,474
healthy blood donors
Samples were collected at two EFS sites in the Grand Est.
Not patients. Not a selected disease population. Blood donors — recruited where blood is already given.
The second question
How long does DNA keep?
Every stored sample represents a promise: that it will still be readable later.
ApoDiag turned that promise into a measurement.
The same PAXgene DNA samples were assessed at seven timepoints over two years, at two storage temperatures.
−20 °C−80 °C
- Baseline
- 24 hours
- 5 days
- 28 days
- 3 months
- 12 months
- 24 months
7 measurements. 24 months. 2 temperatures.
From collection through two years of storage, the study tracked whether the DNA remained suitable for analysis.
The scale is logarithmic: a linear one would crush the first five readings into a centimetre.
Who took part
Blood donors, not patients.
Recruiting through blood donation centres meant participants could contribute without making a separate trip to a study clinic.
Participants were healthy adults, and each provided two separate consents: one for sample collection and one for APOE genotyping.
3 conditions · 3 exclusionsVerdict
- 01Signed informed consent for sample collection and genotypingRequired
- 02Adult, any gender, aged 18–85Required
- 03Not under administrative or legal supervisionRequired
- 04No signed informed consentExcluded
- 05Under 18 or over 85Excluded
- 06Pregnant, giving birth or breastfeedingExcluded
Where
- NancyEFS Grand Est54100
- StrasbourgEFS Grand Est67000
The test
What exactly was validated?
APO-Easy® determines APOE genotype by analysing two single-nucleotide polymorphisms (SNPs):
rs429358 · rs7412
Together, these two variants determine the APOE allele combination a person carries.
On a partner-facing page, “APOE genotyping” is the headline. The specification is rs429358 + rs7412.
For what these variants mean clinically, see the Alzevit study page.
APO-Easy®Amoneta
- Method
- Real-time PCR
- Detects
- rs429358rs7412
- Sample types
- Whole blood · Saliva · Buccal swab
- Regulatory status
- CE-marked under the EU IVDR since August 2024
Registration & governance
Filed. Numbered. Public.
- ClinicalTrials.gov
- NCT06432192 · First posted 29 May 2024
- National reference
- RCB 2023-A02120-45
- Participants
- Healthy volunteers recruited among blood donors
- Sample
- Whole blood collected in PAXgene DNA tubes
- Consent
- Two separate consents: sample collection and genotyping
- Status
- Completed · 25 March 2025
Study leadership
- Huseyin Firat, MD, PhDStudy Director
- Stéphanie Boutillier, PhDStudy Director
- Lucas Pham-Van, PhDStudy Chair
- Joanna MichelStudy Chair
Don’t take our word for it.
The study was registered before enrolment began. Its objectives, design and governance were declared in advance and are publicly available.
NCT06432192, on clinicaltrials.gov.