The blood-based test is aimed at aiding the initial assessment for Alzheimer’s disease and other causes of cognitive decline in the primary-care setting in patients aged 55 and older.
Roche (RHHBY) on Monday stated that the U.S. Food and Drug Administration has approved the Elecsys pTau181 test developed in collaboration with Eli Lilly and Co. (LLY) for the detection of Alzheimer’s disease.
The blood-based test is aimed at aiding the initial assessment for Alzheimer’s disease and other causes of cognitive decline in the primary-care setting in patients aged 55 and older presenting with signs, symptoms, or complaints of cognitive decline. It measures the phosphorylated Tau (pTau) 181 protein in human plasma.
“By bringing Alzheimer’s blood-based biomarker testing into primary care, we can help patients and their clinicians get answers sooner to support them earlier in their journeys,” said Brad Moore, President and CEO of Roche Diagnostics North America.
Roche also noted that Alzheimer’s biomarker testing has largely been limited to specialty settings, such as neurology.
The performance of the test was evaluated in a clinical study with 312 participants. The results showed that in an early disease-stage, low-prevalence population reflective of a primary-care setting, Elecsys pTau181 could rule out Alzheimer’s pathology with a 97.9% negative predictive value. A high NPV indicates that a negative test result is a reliable indicator of not having the condition, minimizing the risk of a false negative result.
Roche also recently received CE Mark certification in Europe for the Elecsys pTau181 test.
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RHHBY stock is up by about 30% this year, while LLY gained 7%.
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