Amoneta Diagnostics obtains CE-marking certification under the IVDR for APO-Easy® Genotyping Kit

Amoneta Diagnostics SAS, a biotech company specialized in developing innovative biomarkers for neurodegenerative disease, proudly announces that its APO-Easy® Genotyping Kit has achieved CE-marking under the EU In Vitro Diagnostic Regulation 2017/746

Huningue, France – 20/08/2024 – Amoneta Diagnostics SAS, a biotech company specialized in developing innovative biomarkers for neurodegenerative disease, proudly announces that its APO-Easy® Genotyping Kit has achieved CE-marking under the EU In Vitro Diagnostic Regulation 2017/746 (IVDR). The IVDR certification was issued by the Notified Body BSI after successful stages 1 & 2 audits and technical documentation assessment. It allows the marketing and distribution of the APO-Easy® genotyping kit across the Europe, marking a significant step forward in Amoneta’s mission to improve care for patients with neurodegenerative diseases.

“We are delighted to announce that our APO-Easy® Genotyping Kit has achieved CE-marking under the IVDR," said Stéphanie BOUTILLIER, CEO of Amoneta Diagnostics SAS. "This achievement is the result of several years of dedicated work by our team, for developing a solution that meets the specific needs of clinicians and biological diagnostic laboratories. This milestone highlights our commitment to quality and innovation, ensuring we provide a reliable and effective tool that will make a significant impact in medical diagnostics."

CE-marking under the EU IVDR represents a crucial milestone for the APO-Easy® Genotyping kit.

This certification signifies that the test meets the stringent safety, quality, and performance requirements established by the IVDR, ensuring its reliability and effectiveness in medical diagnostics.

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. By using fluorescently labeled probes (FAM and VIC), the kit enables accurate allelic discrimination and APOE genotype determination from human genome. APO-Easy® Genotyping Kit can be used in any certified diagnostic laboratory or healthcare provider facility.

“Considered before 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,” said Prof. Audrey GABELLE, PU-PH, Neurologist at the CHU Gui de Chauliac of Montpellier (France). “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.”

The APO-Easy Genotyping Kit is currently under review by the FDA for its IVD approval in the US, which is expected 4Q-2024/1Q-2025.

About APO-Easy® Genotyping Kit

Key Features:

- Utilizes qPCR with fluorescently labeled probes for high-precision genotyping, ensuring accurate detection of the -ε2, -ε3, and -ε4 alleles.

- Delivers 100% specificity and reliability, with no false positive or false negative results.

- Clinically validated through multicentric studies involving ~960 patients across seven countries with various neurodegenerative conditions, including Alzheimer’s Disease (AD), Mild Cognitive Impairment (MCI), Frontotemporal Dementia (FTD), Lewy Body Dementia (LBD), Parkinson’s Disease Dementia (PDD), Cortico-Basal Degeneration (CBD), and Progressive Supranuclear Palsy (PSP).

About Amoneta Diagnostics SAS

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.

For more information about the APO-Easy® Genotyping Kit and our comprehensive diagnostic solutions, please visit www.amoneta-diagnostics.com or contact apo-easy@firalis.com.