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Roche’s Elecsys® pTau181 becomes the only FDA-cleared blood test for use in primary care to rule out Alzheimer’s-related amyloid pathology
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The Elecsys pTau181 test from Roche received FDA clearance establishing it as the only blood-based biomarker (BBM) test approved for use in the primary-care setting to aid in the initial assessment of patients for Alzheimer’s disease and other causes of cognitive decline.

Intended for patients aged 55 and older presenting with symptoms of cognitive decline, the minimally invasive test measures the phosphorylated Tau (pTau) 181 protein in human plasma, a key biomarker for Alzheimer’s pathology, including both amyloid plaques and tau aggregates.

Developed in collaboration with Eli Lilly and Company, the test’s primary clinical benefit is its ability to help clinicians rule out Alzheimer’s-related amyloid pathology in patients during the early stages of cognitive impairment. This is critical because an estimated 92% of patients with mild cognitive impairment currently go undiagnosed. By integrating biomarker testing into primary care, the Elecsys pTau181 test is expected to significantly broaden patient access to early assessment and improve referral quality to specialists, allowing neurologists to focus their resources on patients most likely to need advanced evaluation and treatment.

The test’s performance, evaluated in a multicenter study, demonstrated a 97.9% negative predictive value (NPV) for ruling out Alzheimer’s pathology in an early-stage, low-prevalence population, which is reflective of the primary-care setting. Since the test is fully automated on Roche’s extensive installed base of instruments across the United States, laboratories can quickly integrate the technology at scale, helping to reduce delays and expand testing availability nationwide. The new clearance makes the Elecsys pTau181 test a central component of Roche’s growing diagnostics portfolio aimed at transforming Alzheimer’s diagnostic pathways by providing information that can potentially reduce the use of more invasive and costly procedures, such as PET scans and cerebrospinal fluid (CSF) testing, thereby improving efficiency and cost-effectiveness across the healthcare system. The FDA clearance follows Roche’s recent receipt of the CE Mark certification in Europe for the same test, underscoring the company’s global commitment to expanding access to minimally invasive tests for earlier detection of neurological diseases.

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