APO-Easy®: CE-IVDR Genotyping kit for the determination of two APOE SNPs related to Alzheimer's.
The APOE gene on chromosome 19, responsible for coding apolipo-protein E, is genetically linked to both common late-onset familial and sporadic forms of Alzheimer’s. The human APOE gene comprises three alleles: -ε2, -ε3, and -ε4 distributed in the population at 7%, 79%, and 14%, respectively.
Having one or two copies of the ε4 allele in APOE gene is statistically associated with an increased risk of developing Alzheimer’s. Approximately 65% of Alzheimer’s Disease (AD) patients in the Caucasian population carry the APOE ε4 allele.
Backed by clinical science, the CE-IVDR APO-Easy® Genotyping Kit is a result of an extensive research and an innovative and highly-sensitive product clinicially validated by multicentric clinical studies in 7 countries on 3,000+ patients with neurodegenerative diseases including patients with Mild Cognitive Impairment (MCI), mild and moderate to severe AD, Frontotemporal Dementia (FTD), Lewy Body Dementia (LBD), Parkinson Disease Dementia (PDD), Cortico-Basal Degeneration (CBD) and Progressive Supranuclear Palsy (PSP).
The APO-Easy® Genotyping kit is a CE-IVDR qualitative in vitro diagnostic (IVD) test based on RT-PCR, intended for the detection of two single-nucleotide-polymorphisms (SNP) rs429358 and rs7412 in human genomic DNA from whole blood, saliva and buccal swab through the use of fluorescently labeled probes (FAM and VIC) allowing allelic discrimination and determination of six Apolipoprotein E (APOE) genotypes: e2/e2, e2/e3, e3/e3, e2/e4, e3/e4, and e4/e4.
- 100% specific, reliable and accurate
- No false positive or false negative results
- Determination of -ε2, -ε3, and -ε4 alleles
accuracy rate
reduction in master mix volume
hours to run the APO-Easy® test
minimal gDNA quantity
Streamlined Process
Less than 2 hours to complete the entire process
*When extracted DNA is used
It empowers you with the means necessary to obtain swift and accurate results, enabling you to make more informed medical decisions as a professional for patients with neurodegenerative conditions. For a visual demonstration, watch our video detailing the protocol.
Access the FDA-approved Instructions for Use (IFU) for APO-Easy®
Access the CE-Marked Instructions for Use (IFU) for APO-Easy®
Genotyping Method Comparison
Alzheimer’s Disease genotyping involves identifying genetic variations, using molecular biology techniques such as PCR, Sanger sequencing, and Next-Generation Sequencing (NGS). Method selection depends on study goals, scale, cost, and desired resolution.
Sanger sequencing : Moderate
NGS : High
PCR genotyping : Low to moderate
Sanger sequencing : Days
NGS : Days to weeks
PCR genotyping : Hours
Sanger sequencing : Low
NGS : High
PCR genotyping : Moderate to high
Key Assay Parameters
Kit storage
Operating time
30 minutes for plate preparation and 1 hour and 29 minutes for the PCR cycle.
Sample storage
Assay validation
Frequently Asked Questions
Everything you need to know about our APO-Easy® Genotyping Kit.
Yes, APO-Easy® received CE-IVDR certification in July 2024 and was FDA-cleared in June 2025.
The kit has been validated on Opus DX (Bio-Rad) and QuantStudio 5 (Thermo Fisher) platforms.
It is recommended to use a Nanodrop spectrophotometer to measure absorbance ratios (A260/280 and A260/230). These ratios help evaluate DNA quality and indirectly assess stability over time.
Yes, a note from PreAnalytiX is available, indicating that DNA extracted from PAXgene DNA tubes remains stable for up to 10 years at +4°C and -20°C.
The kit includes all reagents needed for two-SNP APOE genotyping (rs429358 and rs7412) across 32 reactions per SNP:
2 TaqMan™ Genotyping Master Mix vials (one per SNP)
5 positive control standards: Wild-type, mutant, and heterozygous controls for both SNPs
1 vial of no-template control (NTC)
Link to the Instructions for Use (IFU) detailing workflow and plate layout
Each kit contains 32 reactions, of which 8 are reserved for standards and controls (positive, negative, standards). This leaves 24 reactions available for patient samples.
Using a newer version of the Nanodrop will not have an impact on the CE-IVDR marking. What’s important is to have a quantification and an indication of the quality of the DNA.
If you have any more questions, reach out to our experts.
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