Roche Holding AG (RHHBY) Wednesday said it received CE Mark for its Elecsys pTau181 test, a minimally invasive blood test to help rule out Alzheimer's disease.
The test, which has been developed in collaboration with Eli Lilly and Company, measures phosphorylated Tau (pTau) 181 protein which is an indicator of amyloid pathology, a hallmark of Alzheimer's disease. This test will avoid the need for further confirmatory investigation for patients who test negative.
The CE Mark for the Elecsys pTau181 blood test was based on data from a study which showed the test was able to rule out Alzheimer's disease with 93.8% accuracy.
"With Elecsys pTau181, doctors can give patients and their caregivers the clarity they need when establishing the cause of cognitive decline. By enabling an earlier and less invasive diagnosis, this test has the potential to improve patient outcomes and decrease costs for healthcare systems worldwide," said Matt Sause, CEO of Roche Diagnostics.
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