Aug 24 (Reuters) – The U.S. Food and Drug Administration has cleared Roche and partner Eli Lilly’s blood \u200ctest to help identify signs of Alzheimer’s disease in \u200cpeople aged 55 and older with cognitive decline.<\/p>\n
The test, Elecsys pTau217, is \u200ba biomarker blood test that can help doctors identify patients who are likely or unlikely to have Alzheimer’s-related brain changes, Roche said on Monday.<\/p>\n
The FDA clearance follows European approval for the \u200ctest in May.<\/p>\n
The \u2060test can be run on more than 4,500 Roche laboratory analyzers already installed across the United \u2060States, which the company said could help broaden access.<\/p>\n
Separately, Labcorp and Quest Diagnostics said that they plan to offer the test \u200bthrough \u200btheir laboratory networks, potentially expanding \u200bavailability across the United States.<\/p>\n
Roche \u200cdid not disclose the test’s price.<\/p>\n
Current methods to detect amyloid, a protein linked to the disease, typically rely on positron emission tomography or PET scans or cerebrospinal fluid testing, which can be expensive, invasive and less widely available.<\/p>\n
The FDA \u200cclearance comes as drugmakers and diagnostic \u200bcompanies race to develop simpler tests \u200bfor Alzheimer’s disease amid \u200bgrowing demand for earlier diagnosis and treatment.<\/p>\n
Fujirebio’s \u200cLumipulse became the first blood test \u200bcleared by \u200bthe FDA to aid in the assessment of Alzheimer’s disease in 2025.<\/p>\n
Elecsys pTau217 is not intended to be used \u200bas a standalone \u200cdiagnostic test and results should be interpreted alongside \u200bother clinical information, Roche said.<\/p>\n
(Reporting by Siddhi Mahatole in \u200bBengaluru; Editing by Shinjini Ganguli)<\/p>\n","protected":false},"excerpt":{"rendered":"Aug 24 (Reuters) – The U.S. Food and Drug Administration has cleared Roche and partner Eli Lilly’s blood…\n","protected":false},"author":2,"featured_media":119815,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[124],"tags":[13066,14442,216,134,15704],"class_list":["post-119814","post","type-post","status-publish","format-standard","has-post-thumbnail","category-roche","tag-alzheimer39s-disease","tag-blood-test","tag-eli-lilly","tag-roche","tag-test"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ch\/117151322776831651","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/119814","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/comments?post=119814"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/119814\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media\/119815"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media?parent=119814"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/categories?post=119814"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/tags?post=119814"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}