Cytox launches genoSCORETM-LAB test to predict risk of developing Alzheimer’s disease

Non-invasive genetic test allows doctors to assess an individual’s risk of cognitive decline due to Alzheimer’s disease from a simple saliva sample provided at home

Testing may guide lifestyle interventions to potentially slow disease progression

Cytox Ltd, which provides non-invasive risk assessment and patient stratification tools for Alzheimer’s disease (AD) and dementia, announces the launch of its new genetic test, genoGOAL^TM–LABORATORY, which can predict an individual’s risk of cognitive decline due to Alzheimer’s disease.

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Actions to Take Control of Brain Health (Graphic: Business Wire)

The test analyzes an individual’s genetics against a range of over 100,000 single-nucleotide polymorphisms – common genetic variations – that are associated with or protective against the risk of developing Alzheimer’s disease. This broad genetic analysis allows the test to generate an overall risk of cognitive decline due to the disease.

genoSCORE-LAB only requires a blood or saliva sample. Easy-to-use oral swab allows individuals to provide a home sample if they are self-isolating due to COVID-19, or if they are unwilling or not easily able to visit a facility health. As such, genoSCORE-LAB offers an easy-to-access alternative to existing invasive lumbar puncture tests and expensive scanning procedures.

Dr Richard Pither, CEO of Cytox, commented: “While there are many exciting drug candidates in development to treat Alzheimer’s disease, a full range of effective therapies are still in a few years. However, research has shown that lifestyle changes can significantly reduce the risk of developing Alzheimer’s disease and delay the onset of symptoms. and slow the progression of the disease^(1-5). Our new test can identify patients at highest risk for cognitive decline from Alzheimer’s disease, enabling them to take decisive action to manage their disease progression. “

The story continues

There are several components to the risk of developing Alzheimer’s disease. Depending on an individual’s genetics, they may be born with a higher or lower risk of developing the disease. This genetic risk remains constant, but the overall risk increases with age.

However, that is not the whole story and other external factors can also contribute to the risk of developing Alzheimer’s disease and cognitive decline. Fortunately, there are many positive steps you can take that can delay the onset of Alzheimer’s disease.

With modifiable factors accounting for over 30% of the risk of Alzheimer’s disease, adopting behaviors to monitor and treat factors such as hypertension, type II diabetes, high cholesterol, and smoking has the potential to prolong the time to onset and the rate of cognitive decline in patients with Alzheimer’s disease (see accompanying diagram Taking Control of Brain Health).

Professor Clive Ballard, pro-vice-chancellor for medicine at the University of Exeter, notes: “There are an estimated 10 million people living with dementia worldwide each year, over half of whom have Alzheimer’s disease. The economic impact of the disease is estimated at trillions of dollars per year and is increasing⁶. genoSCORE-LAB has a valuable role to play both in the care of people with dementia and in the critical work to develop new drugs to treat the disease. “

Additionally, genoSCORE-LAB enables developers of novel drug therapies for Alzheimer’s disease to identify and recruit patients for clinical studies, ensuring the selection of the most suitable candidates, most likely to experience cognitive decline over the course of the period of the study.

About Cytox (www.cytoxgroup.com)

Without new drug treatments, the burden of economic and health costs of dementia – including Alzheimer’s disease (AD) – will continue to rise and now exceeds $ 1 billion per year⁶. AD – a very complex disease with risk factors based on genetics, lifestyle, age and environment – has not seen any new drug treatment approved since 2003; and clinical trial failure rates are 99%⁷. Cytox products genoGOAL^TM-LAB and genoTOR^TM use the polygenic risk score (PRS) to predict the risk of developing AD and to improve clinical trial outcomes through patient stratification and genetic characterization of the disease. Cytox genoThe CORE-LAB test has the potential to transform the diagnosis and prognosis of Alzheimer’s disease, opening up a number of new approaches to treat and manage this critical disease. Cytox is ISO 13485 accredited, for the supply of medical devices that meet customer and regulatory requirements.

The references:

1. Prevention, intervention and care of dementia. Lancet. December 16, 2017; 390 (10113): 2673-2734. doi: 10.1016 / S0140-6736 (17) 31363-6

2. The effect of an online cognitive training program in healthy older adults: an online randomized controlled trial J Am Med Dir Assoc. November 1, 2015; 16 (11): 990-7. doi: 10.1016 / j.jamda.2015.06.014.

3. A 2-Year Multidomain Intervention of Diet, Exercise, Cognitive Training, and Vascular Risk Monitoring versus Control to Prevent Cognitive Decline in Elderly at Risk (FINGER): A Randomized Controlled Trial. Lancet 2015; 385: 2255-2263 doi: 10.1016 / S0140-6736 (15) 60461-5

4. Effect of physical activity on cognitive function in older people at risk for Alzheimer’s disease. JAMA. September 3, 2008; 300 (9): 1027-37. doi: 10.1001 / jama.300.9.1027

5. ACTIVE Study Group Long-term effects of cognitive training on daily functional outcomes in the elderly. JAMA. December 20, 2006; 296 (23): 2805-14. doi: 10.1001 / jama.296.23.2805

6. World Alzheimer’s Disease Report 2015 www.alz.co.uk/research/WorldAlzheimerReport2015.pdf

7. The “rights” of precision drug development for Alzheimer’s disease. Alzheimer’s Disease Research and Therapy (2019) 11:76 https://doi.org/10.1186/s13195-019-0529-5

About genoGOAL^TM-LABORATORY (www.genoscore-lab.com)

genoSCORE-LAB is available as a CE marked product in Europe and will be available as a Laboratory Developed Test (LDT) in the United States in the second quarter of 2021.

Doctors can register and order a genoSCORE-LAB test for patients via the web portal. www.genoscore-lab.com

Developers of new drug therapies for Alzheimer’s disease can also access genoSCORE-LAB for clinical trial enrichment, please contact Cytox [email protected]

This test is a measure of the relative risk of future onset of late Alzheimer’s disease (LOAD) and should not be viewed as a stand-alone diagnostic test. A high genoSCORE test result does not indicate that an individual will definitely develop CHARGE in the future, and conversely a low genoSCORE result does not categorically mean that the subsequent onset of CHARGE will never occur. The test result should be used in conjunction with other information available to the doctor. At present, the test is validated for use in people of European descent only.

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Contacts

Cytox Ltd
Richard Pither, Managing Director
Phone: +44 1865 338 018

Media
Adam michael
Phone: +44 777 588 1813
[email protected]