On 13 October, the biotechnology company Roche announced that the US Food and Drug Administration (FDA) has cleared its Elecsys pTau181 test, for use in primary care settings to assist the assessment and diagnosis of Alzheimer's disease (AD). The test is intended for adults 55 years and older in the US who present signs or symptoms of cognitive decline. It measures the phosphorylated Tau (pTau) 181 protein in blood plasma, a key biomarker for AD pathology, including amyloid plaque and tau aggregate pathology. Developed in collaboration with Eli Lilly and Company, this minimally invasive test is designed to help clinicians 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. In a clinical, non-interventional multicentre trial involving 312 participants, Elecsys was able to rule out AD with a 97.9% negative predictive value, said Roche. This clearance marks Elecsys pTau181 as the first blood-based biomarker (BBM) test indicated as an aid in the initial assessment for AD and other causes of cognitive decline in the primary-care setting. It is also the second AD test to gain FDA clearance in 2025; the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test (from Fujirebio) received approval in May. In addition to FDA clearance in the US, Roche recently received CE Mark certification in Europe for the Elecsys pTau181 test, making it the first In Vitro Diagnostic Regulation-certified blood test to help rule out Alzheimer’s-associated amyloid pathology.
https://www.roche.com/investors/updates/inv-update-2025-10-13b