Health
Roche's Elecsys® pTau181 becomes the only FDA-cleared blood test for use in primary care to rule out Alzheimer's-related amyloid pathology
Roche (SIX: RO, ROG; OTCQX: RHHBY) today 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)
About this update from Rogers Corporation
[{"type":"list","items":[{"val":[{"type":"text","content":"Rules out Alzheimer's pathology in early stages to enhance diagnostic pathway efficiency","length":92,"tagName":"p"}]},{"val":[{"type":"text","content":"Provides new opportunity to broaden access and improve referral quality","length":71,"tagName":"p"}]},{"val":[{"type":"text","content":"Features as part of Roche's growing portfolio designed to further shape Alzheimer's diagnostic pathways","length":116,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":279,"olType":false},{"type":"text","content":"INDIANAPOLIS, Oct. 13, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today 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.","length":677,"tagName":"p"},{"type":"image","alt":"Roche Logo (PRNewsfoto/Roche)","displaySize":"","headline":null,"caption":"Roche Logo (PRNewsfoto/Roche)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":208,"url":"https://media.zenfs.com/en/prnewswire.com/ddae411f5257d9a3530e1fa3804c566f"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/eSQDLdZIDYgtsIFVCJlYYQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTM2NztjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/ddae411f5257d9a3530e1fa3804c566f","width":400,"height":208}},"href":"https://mma.prnewswire.com/media/651894/Roche_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"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.","length":338,"tagName":"p"},{"type":"text","content":""By bringing Alzheimer's blood-based ...