Roche Receives FDA Clearance for Elecsys pTau181 — the First Blood-Based Test to Aid in the Early Assessment of Alzheimer’s Disease
Roche today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its Elecsys pTau181 test — the first and only blood-based biomarker (BBM) test indicated to assist in the initial evaluation of Alzheimer’s disease (AD) and other causes of cognitive decline in primary care settings.
Designed for patients aged 55 years and above showing signs or symptoms of cognitive impairment, the Elecsys pTau181 test measures phosphorylated Tau (pTau) 181 protein in human plasma — a critical biomarker associated with Alzheimer’s pathology, including amyloid plaque and tau tangle formation.
Developed in collaboration with Eli Lilly and Company, this minimally invasive test enables clinicians to identify patients in the early stages of cognitive decline who are unlikely to have Alzheimer’s-related amyloid pathology. Test results should always be interpreted alongside other clinical information.
“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.”
Transforming Early Alzheimer’s Assessment
Alzheimer’s disease, a multifactorial condition, affects more than 7 million Americans, yet 92% of patients with mild cognitive impairment — the earliest symptomatic stage — remain undiagnosed. Traditionally, biomarker testing has been confined to neurology or specialty centers.
The FDA clearance of the Elecsys pTau181 test now brings this capability into primary care, potentially expanding patient access and helping clinicians make earlier, more informed referral decisions. By identifying those unlikely to have Alzheimer’s pathology, the test helps preserve specialist resources for patients most in need of advanced assessment and care.
Broad Access and Seamless Integration
With over 4,500 Roche diagnostic instruments already deployed in U.S. laboratories, health systems can easily integrate the Elecsys pTau181 test within their existing infrastructure. Its full automation allows for rapid adoption, facilitating broader access to minimally invasive Alzheimer’s testing across the nation.
A multicenter, non-interventional study involving 312 participants demonstrated that in a primary-care-representative population, Elecsys pTau181 achieved a 97.9% negative predictive value (NPV) in ruling out Alzheimer’s pathology — making it a powerful screening tool in early disease assessment.
Key Advantages for Healthcare Systems
The Elecsys pTau181 test may enable healthcare providers to:
Support early-stage assessment of cognitive decline by helping rule out Alzheimer’s-related amyloid pathology.
Integrate primary care more effectively into the Alzheimer’s diagnostic pathway.
Improve referral quality for advanced evaluation and care.
Optimize specialist resources, focusing neurologists’ time on patients most likely to benefit.
Potentially reduce reliance on invasive and expensive procedures such as PET scans and CSF testing, thereby enhancing cost-efficiency across the healthcare continuum.
A Milestone in Roche’s Alzheimer’s Diagnostics Journey
The FDA clearance represents a pivotal step in Roche’s mission to transform Alzheimer’s diagnostics. Building on this milestone, Roche continues to advance a comprehensive diagnostic portfolio, including CSF assays, blood-based biomarkers, and digital tools — all designed to support earlier and more accurate detection of neurodegenerative diseases.
In addition to the U.S. FDA clearance, Roche has also obtained CE Mark certification in Europe for the Elecsys pTau181 test, making it the first IVDR-certified blood test to help rule out Alzheimer’s-associated amyloid pathology. These dual milestones underscore Roche’s global commitment to expanding access to minimally invasive, high-accuracy Alzheimer’s diagnostics.