Project description
Earlier diagnosis of Alzheimer's by a new genetic assay
Early diagnosis of Alzheimer’s disease relies on testing that is not easily applicable to the broader population. However, early diagnosis for both families and health providers are crucial as its incidence is expected to triple by 2050 from the current estimate of 45 million. The variaTECT method uses 130K single nucleotide polymorphism (SNP) testing and software to analyse DNA extracts from blood or saliva samples. It is 85 % accurate with significant cost savings for patients and revenue for genetic laboratories. The project will upgrade variaTECT’s design to determine dementia types and increase production capacity, aiming for clinical trials for an in-vitro diagnostic device.
Objective
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.
Fields of science
- natural sciencescomputer and information sciencessoftware
- medical and health sciencesbasic medicineneurologydementiaalzheimer
- humanitiesartsarchitectural design
- natural sciencesbiological sciencesgeneticsnucleotides
- engineering and technologymedical engineeringdiagnostic imagingmagnetic resonance imaging
Programme(s)
Funding Scheme
SME-1 - SME instrument phase 1Coordinator
M2 2AN MANCHESTER
United Kingdom
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.