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Roche presents new data at CTAD, demonstrating its growing momentum in diagnostics for Alzheimer’s disease
Roche has announced new data on its Elecsys Amyloid Plasma Panel and Elecsys ptau181 for ruling out Alzheimer's disease related amyloid pathology with very good accuracy. The blood-based test showed high accuracy in ruling out Alzheimer's pathology in those being investigated for the disease, potentially avoiding the need for further invasive and unnecessary tests. The test could allow clinicians to rule out Alzheimer's disease as a possible cause of cognitive symptoms with a simple blood test, offering certainty and reassurance. In a prospective, multicentre study, the Roche Elecsys Amyloid Plasma Panel was able to rule out Alzheimer's disease with a high negative predictive value of 96.2% based on a 23.4% prevalence of amyloid positivity according to positron emission tomography scans. The performance of the test was only minimally impacted by the patients' age, sex, body mass index or impaired kidney function. Roche's pTau181 biomarker performed similarly as a standalone assay. The Elecsys Amyloid Plasma Panel received FDA Breakthrough Device Designation in July 2023 and is a minimally invasive blood test that measures phosphorylated Tau protein and apolipoprotein E4 in plasma. The test is intended for consideration in conjunction with other clinical information to advise for further confirmatory testing with amyloid positron emission tomography or cerebrospinal fluid testing. Roche is committed to using its diagnostic and pharmaceutical capabilities to better detect and treat Alzheimer's disease as early as possible, and working toward preventing the disease altogether.