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A novel genetic assay for risk assessment of cognitive decline in Alzheimer’s Disease


Start Date
End Date
Total Funding
€ 71 429
Funding Programme
European Countries Involved
Alzheimer’s Disease (AD) is the most prevalent cognitive disorder and progressively leads to complete brain dysfunction and degeneration. The number of people living with Alzheimer’s worldwide is now estimated at 46M, with this figure set to almost double by 2030 and more than triple by 2050 due to population aging. Current methods for early assessment of AD are based on detection of β-amyloid in the brain Positron Emission Tomography (PET) scans, blood plasma tests or in cerebrospinal fluid (CSF) (via lumbar puncture). However, these solutions present some unresolved issues for broad market deployment. Cytox has developed the variaTECT platform to stratify AD risk in individuals by using a fast, accurate, reliable and cost-effective way to generate specific genetic information. The variaTECT comprises a proprietary 130K single nucleotide polymorphism (SNP) variaTECT array and the proprietary SNPfitRTM software to analyse data generated from the array. DNA extracted from a patient’s blood or saliva sample is collected and analyzed on the variaTECT array. The primary genetic data are then processed by the SNPfitR software, which provides a risk score associated with the probability to develop AD. variaTECT has an 85% accuracy, it can save up to €10k person-year for the healthcare systems and it can generate new revenues (up to €10M) for genetic labs. During the feasibility assessment, a go-to-market strategy and a supply chain will be established, as well as further development plan will be drafted. During the second phase of innovation project, Cytox will upgrade the array design to increase the number of SNPs and the SNPfitR software to stratify subjects into different dementia types. Production capacity will be increased up to 100,000 pieces per year. Multiple clinical trials will be then initiated to obtain CE mark as In-Vitro Diagnostic (IVD) device.
Project partners
Cytox Limited
Alzheimer Europe's database on research projects was developed as part of the 2020 Work Plan which received funding under an operating grant from the European Union’s Health Programme (2014–2020).