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APO-Easy® (De Novo FDA-approved & CE-IVDR kit for ApoE Genotyping)

APO-Easy® (De Novo FDA-approved & CE-IVDR kit for ApoE Genotyping)

APO-Easy® (De Novo FDA-approved & CE-IVDR kit for ApoE Genotyping)

Product catalog summary
Product Overview: The APO-Easy® Genotyping kit is a De Novo FDA-approved and CE-IVDR certified product designed for the determination of two ApoE Single Nucleotide Polymorphisms (SNPs) related to Alzheimer’s Disease (AD). It is validated by clinical studies involving over 3,000 subjects, including patients with various neurodegenerative diseases.
Clinical Use: The kit is used in clinics to screen populations for ApoE genotypes, aiding in the establishment of ApoE registries for preventive therapies and mechanistic studies of AD onset. It helps distinguish between AD patients and those with other forms of dementia based on genotype.
Regulatory and Safety Information: The FDA has issued a "black box warning" recommending ApoE ε4 status testing before starting certain treatments due to potential side effects like Amyloid-Related Imaging Abnormalities (ARIA).
Features and Benefits: Developed by Amoneta Diagnostics, a subsidiary of Firalis Group, the kit offers 100% sensitivity and specificity, ensuring no false positives or negatives. It uses qPCR technology with fluorescently labeled probes for allelic discrimination, determining ε2, ε3, and ε4 alleles.
Quality and Certification: The kit is produced under stringent quality management systems, including ISO 9001:2015, ISO 13485:2016, ISO 17025:2017, and ISO 20387:2018 certifications, ensuring high standards in testing and biobanking activities.
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Catalog excerpts

APO-Easy® (De Novo FDA-approved & CE-IVDR kit for ApoE Genotyping)-1

qPCR-based genotyping kit for thedetermination of two ApoE Single Nucleotide Polymorphisms (SNPs) related to Alzheimer's Disease (AD) 1st De Novo FDA-approved & CE-IVDR kit for ApoE Genotyping C € 0459$ Current use in clinics APO-Easy® is a genotyping test for the in vitro determination of the ApoE genetic status. ApoE gene located on chromosome 19, responsible for coding apolipoprotein E, is genetically linked to both common late-on set familial and sporadic forms of AD. ApoE is functionally 'nicea to lipid transport (liver and brain). New anti-beta amyloid therapies may elicit side effects, such as Amyloid-Related Imaging Abnormalities (ARIA), in individuals caring the double e4 allele. FDA included a "black box warning" stating that testing for ApoE e4 status should be performed before starting treatments (Leqembi & Kisunla) to inform patients of their risk of developing aria. Use of APO-Easy® Genotyping kit for population screening to establish ApoE registries for preventive therapies and for mechanistical studies of disease onset in early versus late AD patients. Historically, the genotyping of the ApoE gene can be used as a risk indicator for developing AD when a patient presents Mild Cognitive Impairment (MCI). Indeed, in memory clinics, this tool could distinguish between AD patients and those with other dementia based on their genotype. We are facing a paradigm shift: • A homozygote e4/e4 patient would represent a distinct, fully causal subtype of Alzheimer's disease, and • All e4/e4 patients will develop AD if they live long enough. Backed by clinical science, the De Novo FDA-approved and CE-IVDR APO-Easy® Genotyping kit is a result of an extensive research, an innovative and highly-sensitive product validated by several clinical studies in more than 3,000 subjects, including 960 patients suffering from neurodegenerative diseases such as 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).

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APO-Easy® (De Novo FDA-approved & CE-IVDR kit for ApoE Genotyping)-2

Aspect I Sanger Sequencing I NGS I qPCR genotyping Days Days to weeks Less than 6 hours Low High Moderate to high Tested on over 3,000 samples 100% specific, reliable and accurate No false positive or false negative results Features and benefits The APO-Easy® Genotyping kit sets the current standard in genetic analysis with its remarkable features. Reduced blood sample input: 200pl 100% accuracy, reproducibility and repeatability Assay validated for use on PCR platform Results obtained within 6 hours -from patient to result Amoneta Diagnostics, subsidiary of Firalis Group, is a biotechnology...

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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.