Roche Holding AG has announced that it has received the CE Mark for its Elecsys® pTau181 test, a minimally invasive blood test designed to help rule out Alzheimer's disease. This marks the first In Vitro Diagnostic Regulation (IVDR) certified test aimed at identifying Alzheimer's associated amyloid pathology. Developed in collaboration with Eli Lilly and Company, the Elecsys pTau181 test can serve as a key tool in primary care settings, providing clarity in diagnosing cognitive decline and potentially reducing the need for additional confirmatory testing with a negative result. This approval follows a comprehensive global clinical study, which assessed the test's performance across a diverse patient population, ensuring its efficacy across various demographics.
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