Amoneta Diagnostics is a French biotech company seeking, developing, and qualifying innovative biomarkers for the development of diagnostic solutions in the field of neurological diseases such as Alzheimer’s Disease to revolutionize patient care and advance precision medicine. The company has a large portfolio of patents related to blood biomarkers, including a new class of non-coding RNAs as diagnostic targets for AD and other types of dementia (on which MemoryLinc® and NeuroLINCs are based-products). In addition to the APO-Easy® Genotyping Kit, Amoneta has also developed the innovative NeuroDeGene® product, which is a DNA-targeted sequencing panel for the detection of more than 15,000 SNPs (including APOE) and INDELS associated with 19 neurodegenerative diseases.
Its flagship product APO-Easy® Genotyping Kit has achieved CE-marking under the IVDR and FDA de novo regulatory approval for the USA market. This achievement is the result of several years of dedicated work by our teams, developing a solution that meets the specific needs of clinicians and biological diagnostic laboratories.
The APO-Easy® Genotyping Kit represents a major advancement in diagnostic technology. It is a ready to use qualitative in vitro diagnostic (IVD) test based on Real-Time Polymerase Chain Reaction (RT-PCR), designed for the precise detection of two single-nucleotide polymorphisms (SNPs): rs429358 and rs7412.
Previously considered as a risk factor for Alzheimer’s Disease, recent literature reported increasing value of the APO-E4 genotype as an early diagnostic marker, alone or in combination with other emerging biomarkers. For patients who are eligible for new anti-amyloid drugs, APOE genotyping is now recommended by the FDA for better monitoring of adverse effect induced by these disease-modifying therapies, demonstrating the importance of tests such as the APO-Easy® Genotyping Kit.
For more information about our comprehensive diagnostic solutions, visit https://amoneta-diagnostics.com/products/ or send a message to contact@amoneta-diagnostics.com
More information about the APO-Easy® Genotyping Kit can be found at https://amoneta-diagnostics.com/products/apo-easy/
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Originally published by Amoneta Diagnostics on 20 August 2024.
