Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer's disease
Basel: Roche has announced it has received CE Mark for its Elecsys pTau181 test to measure phosphorylated Tau (pTau) 181 protein which is an indicator of amyloid pathology, a hallmark of Alzheimer's disease. The test, which has been developed in collaboration with Eli Lilly and Company, can be used by clinicians in conjunction with other clinical information to rule out Alzheimer’s disease as the cause of cognitive decline. This could avoid the need for further confirmatory investigation for patients testing negative.
“The burden of Alzheimer’s disease on society and healthcare systems is increasing as the world’s population ages,” said Matt Sause, CEO of Roche Diagnostics. “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.”
Barriers to early and accurate diagnosis of Alzheimer’s disease exist across the world. Up to 75% of people living with symptoms are not diagnosed, and those who have received a diagnosis waited nearly three years on average after symptom onset. The identification of amyloid pathology is critical for Alzheimer’s diagnosis and treatment. Current methods to confirm amyloid pathology - including positron emission tomography (PET) and cerebrospinal fluid (CSF) assessment - can be expensive, difficult to access and invasive. With a negative Elecsys pTau181 blood test, people can avoid further unnecessary investigations for Alzheimer’s using CSF or PET and can identify the care pathway that is right for them.
Clinical study results support that the test can be implemented effectively across care settings, including primary care, where most patients first seek help for cognitive concerns. Those with positive results are then able to undergo further testing, supporting earlier identification of Alzheimer’s pathology.
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