Validation of a fast and simple peripheral blood test for the diagnosis of Alzheimer’s disease.
Alzheimer’s Disease (AD) is the most common form of dementia (60 to 70% of the overall dementia cases). Approximately 46.8 million people worldwide currently live with AD or other type of dementia. With an ageing population, this number is estimated to increase to 131.5 million by 2050 (World Alzheimer Report, 2015:
http://www.alz.co.uk/research/WorldAlzheimerReport2015.pdf(odnośnik otworzy się w nowym oknie)). Currently, no accurate blood In-Vitro diagnostic (IVD) test to diagnose AD exists. A potential AD diagnosis is usually given by a combination of clinical examination, neuropsychological tests and neuroimaging, over several months or years. In addition, a lumbar puncture can be performed to detect biomarkers in cerebrospinal fluid, but this procedure is invasive. Consequently, AD clinical diagnosis is a real challenge for physicians!
Rapid and reliable tests, based on peripheral biomarker detection, represent one of the most promising tracks to diagnose the pathology, to facilitate patient stratification and the assessment of efficacy of new AD therapeutic drug candidates under development in clinical trials.
Amoneta Diagnostics SAS has developed a diagnostic kit candidate based on blood biomarkers, which allows the diagnosis of AD using only one single blood sample, in a fast, non-invasive way. In this project, a large Proof-of-Performance (PoP) clinical study in AD patients was conducted for the clinical validation of blood biomarkers, both erythrocyte cell biomarkers as primary objective and novel circulating coding and non-coding RNAs and protein biomarkers. The project is supported by the European federation of AD patients’ associations, the Alzheimer Europe. Its successful implementation and results will have a strong impact on the quality of life of patients and a significant impact on the healthcare system and economy. As a result of the present project, the validated and most accurate blood biomarker test will be available as Research-Use-Only (RUO) product for clinical applications from 4Q 2019 and is being CE-marked as approved IVD product for diagnostic applications in 2020.
< See attached picture - 1 : ADDIA test as the first blood cell based IVD test approved for the Alzheimer’s diagnosis. >
The 1st ADDIA test is based on blood cell biomarkers detected by flow cytometry and probes proprietary to Amoneta Diagnostics thanks to its acquired pipeline of patents from the CNRS and the 2nd ADDIA test is based on measurement of patented unique non-coding RNA panels using HTG/NGS technology. The company has recently filled two additional patents on the biomarkers and tests related to the ADDIA project. The most accurate ADDIA validated and CE registered IVD biomarker assay will be available for clinical applications, initial market introduction and further commercialization from 1Q 2020.
