FDA Clears Blood Test for Early Detection of Amyloid Pathology

The Food and Drug Administration (FDA) has cleared the Elecsys^® pTau181 test as an aid in early detection of amyloid pathology in the primary care setting for adults aged 55 years and older presenting with signs, symptoms or complaints of cognitive decline.

The blood-based biomarker test measures Tau protein phosphorylated at threonine 181 in human plasma (pTau181). It has been shown that the accumulation of amyloid‑β plaques triggers tau phosphorylation, making it a key biomarker for Alzheimer disease pathology. A negative Elecsys pTau181 test indicates a lower likelihood of Alzheimer-related amyloid pathology.    

The FDA clearance was supported by data from a non-interventional clinical study that included 312 participants with cognitive complaints. Findings showed testing with Elecsys pTau181 helped to rule out Alzheimer pathology with a 97.9% negative predictive value in this early disease-stage population. 

According to Roche, the test is expected to have a positive impact on health care efficiency and cost by improving referral quality and potentially reducing the use of more invasive and expensive procedures.

“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. “This milestone reflects Roche’s leadership in diagnostics and our commitment to expanding access to innovative testing for patients and their clinicians.”

The Elecsys pTau181 test should be considered an aid in the initial assessment of Alzheimer disease and results should be interpreted in conjunction with other clinical information. 

This article originally appeared on MPR