Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer’s disease

Roche has received CE Mark for its Elecsys pTau181 test, which measures phosphorylated Tau 181 protein, an indicator of amyloid pathology in Alzheimer's disease. The minimally invasive, blood-based test can rule out Alzheimer's pathology, reducing the need for confirmatory testing with a negative result. The test has been developed in collaboration with Eli Lilly and Company and can be used by clinicians in conjunction with other clinical information to rule out Alzheimer's disease as the cause of cognitive decline. Data from a clinical study supports the use of the test in primary care for people with varying signs of cognitive decline. The study showed the test was able to rule out Alzheimer's disease with a high negative predictive value of 93.8%. The test's rule-out performance was only minimally impacted by patients' age, gender, body mass index, or impaired kidney function. Roche is also developing the Elecsys pTau217 blood test, which has shown promising results in detecting amyloid pathology. The company has been working towards a day when Alzheimer's disease can be detected and treated early to preserve patients' identities. Roche's Alzheimer's disease portfolio spans investigational medicines, digital, blood-based tests, and CSF assays, aiming to more effectively detect, diagnose, and monitor the disease. The company will continue to work with partners to transform millions of lives affected by Alzheimer's disease.