Eli Lilly and Company, in partnership with Roche, has received clearance from the U.S. Food and Drug Administration (FDA) for their blood test designed to aid in the initial assessment of Alzheimer's disease. The test, named Elecsys pTau181, is intended for use in patients aged 55 and older who are showing signs of cognitive decline. This diagnostic tool measures the pTau181 protein, a key biomarker associated with Alzheimer's. The approval is significant as it provides a less invasive and more accessible method for early assessment compared to traditional methods like spinal taps or PET scans, potentially speeding up diagnosis and access to treatment. In a clinical study involving 312 participants, the test demonstrated a 97.9% negative predictive value in ruling out Alzheimer's.
Eli Lilly and Partner Roche Gain FDA Approval for Alzheimer's Blood Test
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