Roche Alzheimer ’s disease Cerebrospinal Fluid (CSF) assays receive FDA clearance, supporting more accurate and timely diagnosis

TheElecsys® Alzheimer’s disease (AD) CSF assays will be available on thecobas fully automated immunoassay analyzers, enabling patients to get broad access to high quality testing in a timely manner.Greater accessibility and lower cost means these assays could accelerate the path to diagnosis for people with Alzheimer ’s disease.The assays are easily scalable to meet the imminent demand for Alzheimer ’s disease modifying therapies as they become available.Basel, 8 December 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that its Elecsys ® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Phospho-Tau (181P) CSF (pTau181) assays have received U.S. Food and Drug Administration (FDA) 510(k) clearance. The Elecsys AD CSF Abeta42 and pTau181 assays (used as a pTau181/Abeta42 ratio) measure two biomarkers that are hallmarks of Alzheimer ’s pathology, beta-amyloid and tau proteins, in adults ages 55 and older being evaluated for the disease.Currently, the diagnosis of Alzheimer ’s is a diagnosis of exclusion, largely based on various cognitive tests, routine laboratory tests and structural imaging (MRI or CT scan). Clinical criteria are currently limited and lead to an accurate diagnosis in only 70-80% of cases.1To increase diagnosis accuracy, an amyloid positron emission tomography (PET) scan, that measures the build-up of abnormal beta-amyloid protein in the brain, can be used as an adjunct to these evaluations.2.However, the high cost, limited availability, a...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news