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Cytox Gets CE Mark for Alzheimer's Disease Genetic Risk Test

NEW YORK – Cytox said on Wednesday that it has garnered CE marking for its GenoScore-Lab genetic risk test for Alzheimer's disease and has launched the test in Europe.

GenoScore-Lab analyzes an individual's genes for more than 100,000 SNPs associated with the risk of developing Alzheimer's disease. According to a company spokesperson, the test runs on a custom Axiom array on the Thermo Fisher Scientific GeneTitan platform.

This analysis measures relative risk for late-onset Alzheimer's disease, should not be considered a standalone diagnostic test, and should be used in conjunction with other information available to a physician, the company said. It is currently validated for use in individuals of European ancestry only.

The assay requires either a blood or saliva sample, and a mouth swab is available for individuals to collect samples at home if they are unable to travel to a healthcare setting, Cytox said. The spokesperson noted that the sample type doesn't affect test results, and that the company anticipates saliva being predominantly used, though some patients may receive the assay after having provided blood for a range of tests.

"While there are many exciting drug candidates in development to treat Alzheimer's disease, a comprehensive suite of effective therapeutics is still some years away," Cytox CEO Richard Pither said in a statement. "However, research has shown that lifestyle changes can significantly mitigate the risk of developing Alzheimer's disease, delay the onset of symptoms, and slow the rate of disease progression. Our new test can identify those patients most at risk of cognitive decline due to Alzheimer's, enabling them to take decisive action to manage their disease progression."

Cytox said the assay is also intended to enable Alzheimer's disease drug developers to identify and recruit patients to clinical studies, choosing those most likely to experience cognitive decline over the course of a study.

GenoScore-Lab will be available as a laboratory-developed test in the US in the second quarter of this year, Cytox said.

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