Roche announced that the United States Food and Drug Administration (FDA) has cleared its Elecsys pTau181 test, the only blood-based biomarker (BBM) test indicated as an aid in the initial assessment for Alzheimer’s disease and other causes of cognitive decline in the primary-care setting.
The Elecsys pTau181 test is intended for patients ages 55 and older presenting with signs, symptoms or complaints of cognitive decline. It measures phosphorylated Tau (pTau) 181 protein in human plasma, a key biomarker for Alzheimer’s pathology, including amyloid plaque and tau aggregate pathology.
Developed in collaboration with Eli Lilly and Company, this minimally invasive test provides clinicians with information that can help identify patients in early stages of cognitive decline who are unlikely to have Alzheimer’s-related amyloid pathology. The result should be interpreted in conjunction with other clinical information.
By enabling use in primary care, the Elecsys pTau181 test has the potential to significantly broaden patient access to minimally invasive testing and helps preserve specialist resources. Primary care clinicians can better guide appropriate referrals so neurologists can focus on the patients most likely to need advanced evaluation and treatment.
Elecsys pTau181 is the only FDA-cleared, blood-based Alzheimer’s test indicated as an aid in the initial assessment for Alzheimer’s and other causes of cognitive decline in the primary-care setting. The performance was evaluated in a multicenter, non-interventional clinical study in 312 participants. Results demonstrated that in an early disease-stage, low-prevalence population reflective of primary-care setting, Elecsys pTau181 could rule out Alzheimer’s pathology with a 97.9% negative predictive value (NPV). Fully automated on Roche’s installed base of instruments, Elecsys pTau181 allows laboratories to integrate testing quickly and at scale – creating new opportunities to broaden access and reduce delays for patients and their providers.
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