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

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.

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Topic(s)

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Funding Scheme

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SME-1 - SME instrument phase 1

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Call for proposal

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(opens in new window) H2020-EIC-SMEInst-2018-2020

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Coordinator

CYTOX LIMITED
Net EU contribution

Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.

€ 50 000,00
Address
53 FOUNTAIN STREET
M2 2AN MANCHESTER
United Kingdom

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
North West (England) Greater Manchester Manchester
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
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Total cost

The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.

€ 71 429,00
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