Noninvasive Genetic Risk Test for Alzheimer’s Coming to EU, US

Cytox has launched a noninvasive genetic test, called genoSCORE-LAB, that can help to predict a person’s risk of developing Alzheimer’s disease and the cognitive decline it brings.

Early detection of possible risk for this progressive, degenerative disease could encourage lifestyle changes that might slow Alzheimer’s onset and the rate of cognitive loss, the company reports in a press release.

The test, which uses a blood or saliva sample, has received the CE mark in Europe, and will also be available in the U.S. by the close of June, the company announced.

The CE mark is issued by the European Commission for products have been assessed to meet pre-established safety, health, and environmental protection requirements. In the U.S., this test is considered a laboratory developed test and, at present, does not require FDA approval.

“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,” said Richard Pither, PhD, CEO of Cytox.

The risk of developing Alzheimer’s has several components, including genetics. A number of genes have been identified that may be linked to disease development. Although this genetic risk remains constant, the overall risk for Alzheimer’s is thought to increase with age.

External factors are also reported to account for more than 30% of the risk of developing Alzheimer’s and cognitive decline. These include hypertension, diabetes, elevated cholesterol levels, and smoking.

“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,” Pither said.

genoSCORE-LAB analyzes a person’s genetic information against a collection of more than 100,000 single nucleotide polymorphisms (small gene variants) that are associated with, or are protective against, Alzheimer’s disease.

Cytox reports that its genoSCORE-LAB only requires a saliva or blood sample that could be collected at a clinic, or through a mouth swab done at home. It can only be ordered by a physician, and costs are not covered by public healthcare plans or private insurers at this time, the company reports on a webpage.

An Alzheimer’s risk determination is based on the evaluation of the contribution of different combined genetic risk factors or polygenic risk scores.

However, the company notes that test findings are not conclusive, and constitute only a measure of relative risk of possible disease onset. A high test result does not indicate a person will develop Alzheimer’s, and a low result does not mean a person will not develop it.

At present, the test is validated for use solely with people of European ancestry. Physicians can register and order a genoSCORE-LAB test at a patient’s request, should they agree to the test, through the company’s website. Results are returned to the ordering physician.

“Globally an estimated 10 million people develop dementia each year, with more than half as Alzheimer’s disease. The economic impact of the disease is estimated at trillions of dollars a year, and is rising,” said Clive Ballard, MD, professor at the University of Exeter.

“genoSCORE-LAB has a valuable role to play in both the management of people with dementia, and the critical work to develop new drugs to treat the disease,” Ballard added.