FDA Clears New Blood Test for Alzheimer Disease in Primary Care Settings
On Monday, the US Food and Drug Administration (FDA) cleared the Elecsys pTau181 blood-based biomarker test to aid in the initial assessment for Alzheimer disease (AD) and other causes of cognitive decline, for use in primary care settings. The test was developed by Roche and Eli Lilly and Company.
The Elecsys pTau181 test is indicated for patients 55 and older presenting with signs, symptoms, or complaints of cognitive decline, and is designed to be used in conjunction with other clinical information to diagnose AD. It works by measuring phosphorylated Tau (pTau) 181 protein in human plasma which is a key biomarker for the amyloid plaque and tau aggregate pathology behind AD.
>>NEWS: Noninvasive Physiomarker Identifies MCI and AD With High Accuracy
“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, in a news release. “This milestone reflects Roche’s leadership in diagnostics and our commitment to expanding access to innovative testing for patients and their clinicians.”
The clearance of the Elecsys pTau181 test is supported by data from a multicenter, non-interventional clinical study involving 312 participants who reflected the early disease-stage, low-prevalence population most likely to present in a primary-care setting. Results showed that the test could rule out AD pathology with a 97.9% negative predictive value.
In recent years, more emphasis has been placed on early screening, assessment, and diagnosis of AD due to the availability of monoclonal antibodies, like lecanemab and donanemab, for treatment of early symptomatic cases with confirmed amyloid pathology.
References
