Roche announced that the U.S. Food and Drug Administration (FDA) has cleared the Elecsys pTau181 test — the only blood-based biomarker (BBM) test authorized for use in the primary care setting to aid in the initial assessment of Alzheimer’s disease and other causes of cognitive decline.

Intended for patients aged 55 and older presenting with symptoms of cognitive decline, the Elecsys pTau181 test measures the phosphorylated Tau (pTau) 181 protein in human plasma — a key biomarker associated with Alzheimer’s-related amyloid plaque and tau pathology. Developed in collaboration with Eli Lilly and Company, this minimally invasive test helps clinicians identify patients in the early stages of cognitive decline who are unlikely to have Alzheimer’s-related amyloid pathology. Results should 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 — supporting them earlier in their diagnostic journey,” said Brad Moore, President and CEO of Roche Diagnostics North America. “This milestone underscores Roche’s leadership in diagnostics and our commitment to broadening access to innovative testing solutions.”

Alzheimer’s disease affects more than 7 million Americans, yet an estimated 92 per cent of individuals with mild cognitive impairment — an early symptomatic stage — remain undiagnosed. Until now, biomarker testing for Alzheimer’s has largely been limited to specialized settings such as neurology.

With the FDA clearance of Elecsys pTau181, primary care clinicians can now access a high-performing, minimally invasive tool to help rule out Alzheimer’s-related pathology earlier, improving the quality of referrals and allowing specialists to focus on patients with the greatest need.

The FDA clearance of Elecsys pTau181 represents a major milestone in Roche’s mission to transform Alzheimer’s diagnostics. By integrating primary care into the diagnostic pathway, the test offers a new opportunity to improve early assessment, reduce the need for more invasive and costly procedures such as PET imaging and cerebrospinal fluid (CSF) testing, and enhance overall healthcare efficiency.

This achievement complements Roche’s broader innovation strategy in neurological diagnostics. The company continues to advance a comprehensive portfolio aimed at enabling earlier and more accurate detection of neurodegenerative diseases while simplifying laboratory operations.

In addition to U.S. FDA clearance, Roche recently obtained CE Mark certification for Elecsys pTau181 in Europe, making it the first In Vitro Diagnostic Regulation (IVDR)-certified blood test to help rule out Alzheimer’s-associated amyloid pathology. Together, these regulatory milestones highlight Roche’s global leadership in expanding access to minimally invasive Alzheimer’s testing — empowering clinicians, patients, and caregivers with earlier clarity in the diagnostic journey.