The US Food and Drug Administration has cleared the Elecsys Phospho-Tau (217P) Plasma blood test to aid in identifying amyloid pathology associated with Alzheimer's disease among patients aged 55 years and older with signs, symptoms, or complaints of cognitive decline, according to a press release from Roche. The single-biomarker assay supports both rule-in and rule-out assessment of amyloid pathology.
Elecsys pTau217 was developed in collaboration with Eli Lilly and Company. The test returns 1 of 3 result classifications—positive, intermediate, or negative—to inform assessment of whether amyloid pathology is likely. The results are considered alongside clinical information and other relevant findings when evaluating patients for Alzheimer's disease.
The assay was evaluated in patients aged 55 years and older with signs, symptoms, or complaints of cognitive decline associated with Alzheimer's disease. Results from Elecsys pTau217 were highly concordant with amyloid positron emission tomography (PET) imaging in the evaluation, according to Roche.
According to Roche, the blood test may help physicians identify patients with a high or low likelihood of amyloid pathology and determine who should be considered for further testing. The company stated that the assay may also help physicians determine when additional evaluation, including PET imaging or cerebrospinal fluid (CSF) testing, is appropriate.
The assay is designed for use on more than 4,500 Roche cobas laboratory instruments installed in US clinical laboratories. According to Roche, it can be incorporated into existing laboratory workflows without requiring additional instrumentation.
The assay is intended to be used with other components of the diagnostic evaluation rather than on its own. Test results should be considered alongside other clinical information and diagnostic findings. The assay has not been established as safe and effective for predicting future dementia or other neurologic conditions or for tracking responses to therapeutic products.
“Advances in blood-based biomarkers have the potential to transform the diagnostic pathway by expanding access to evaluation for Alzheimer's across a variety of care settings,” said Jared R. Brosch, MD, neurologist at Indiana University Health.
Source: Roche
