{"id":119892,"date":"2026-08-24T17:53:54","date_gmt":"2026-08-24T17:53:54","guid":{"rendered":"https:\/\/www.europesays.com\/ch\/119892\/"},"modified":"2026-08-24T17:53:54","modified_gmt":"2026-08-24T17:53:54","slug":"fda-clears-roche-and-eli-lillys-alzheimers-blood-test-2","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ch\/119892\/","title":{"rendered":"FDA Clears Roche And Eli Lilly\u2019s Alzheimer\u2019s Blood Test"},"content":{"rendered":"<p>Topline<\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">The Food and Drug Administration has cleared a new blood test from Roche and Eli Lilly designed to help identify symptoms related to Alzheimer&#8217;s disease in patients over age 55, Roche said on Monday morning.<\/p>\n<p><img alt=\"Food And Drug Administration Headquarters In Maryland\" loading=\"lazy\" width=\"958\" height=\"539\" decoding=\"async\" data-nimg=\"1\" class=\"rounded-lg\" style=\"color:transparent\" src=\"https:\/\/www.europesays.com\/ch\/wp-content\/uploads\/2026\/08\/https:\/\/media.zenfs.com\/en\/forbes_staff_375\/033a8bf0b3fa472948c2b6f7746e32e9.jpg\"\/><\/p>\n<p>The FDA cleared the new blood test on Monday, Roche and Eli Lilly said in a statement.<\/p>\n<p>Key Facts<\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">The FDA cleared the Elecsys Phospho-Tau (217P) Plasma blood test, which Roche and Lilly say is the single-biomarker blood test designed to test for the likelihood of amyloid pathology, a brain symptom linked with Alzheimer&#8217;s disease.<\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">Doctors could previously diagnose amyloid pathology using PET imaging or cerebrospinal fluid testing\u2014both expensive and invasive procedures.The test was designed to be &#8220;minimally invasive&#8221; and to work easily beside &#8220;existing laboratory workflows,&#8221; Roche and Lilly said, and won&#8217;t require labs to purchase additional equipment.<\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">However, the test was not designed to be a standalone test for Alzheimer&#8217;s and should be interpreted for patients with other clinical information.<\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">Both Labcorp and Quest Diagnostics, two large companies that offer blood testing services, said they planned to start offering the new test.<\/p>\n<p>Key Background<\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">The FDA previously cleared the <a data-ylk=\"slk:first blood test;elm:context_link;itc:0;sec:content-canvas;\" data-yga=\"{&quot;yLinkElement&quot;:&quot;link&quot;,&quot;yLinkElementType&quot;:&quot;article_link&quot;}\" href=\"https:\/\/www.forbes.com\/sites\/antoniopequenoiv\/2025\/05\/16\/fda-greenlights-blood-test-to-diagnose-alzheimers-the-first-of-its-kind\/\" rel=\"noopener noreferrer nofollow\" target=\"_blank\">first blood test<\/a> for Alzheimer&#8217;s last May. That test, developed by Japanese biotech firm Fujirebio, also tests for amyloid plaques in plasma and can be used to &#8220;reliably predict&#8221; amyloid pathology.<\/p>\n<p>Big Number<\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">6.7 million. That&#8217;s how many older adults are living with diagnosed Alzheimer&#8217;s disease in the U.S., according to the <a data-ylk=\"slk:Centers for Disease Control and Prevention;elm:context_link;itc:0;sec:content-canvas;\" data-yga=\"{&quot;yLinkElement&quot;:&quot;link&quot;,&quot;yLinkElementType&quot;:&quot;article_link&quot;}\" href=\"https:\/\/www.cdc.gov\/alzheimers-dementia\/about\/index.html\" rel=\"noopener noreferrer nofollow\" target=\"_blank\">Centers for Disease Control and Prevention<\/a>. This makes it the most common form of dementia, making up between 60% to 80% of all cases. The CDC estimates this figure will double by 2060. However, researchers believe the number of undiagnosed cases of Alzheimer&#8217;s could be much higher. Research published by <a data-ylk=\"slk:Alzheimer&#039;s Disease International;elm:context_link;itc:0;sec:content-canvas;\" data-yga=\"{&quot;yLinkElement&quot;:&quot;link&quot;,&quot;yLinkElementType&quot;:&quot;article_link&quot;}\" href=\"https:\/\/www.alzint.org\/news-events\/news\/over-41-million-cases-of-dementia-go-undiagnosed-across-the-globe-world-alzheimer-report-reveals\/\" rel=\"noopener noreferrer nofollow\" target=\"_blank\">Alzheimer&#8217;s Disease International<\/a> in 2021 found 55 million people across the world suffer from dementia, but about 75% of cases remain undiagnosed.<\/p>\n<p class=\"mb-4 text-lg md:leading-8 break-words\">This article was originally published on <a data-ylk=\"slk:Forbes.com;elm:context_link;itc:0;sec:content-canvas;\" data-yga=\"{&quot;yLinkElement&quot;:&quot;link&quot;,&quot;yLinkElementType&quot;:&quot;article_link&quot;}\" href=\"https:\/\/www.forbes.com\/sites\/zacharyfolk\/2026\/08\/24\/fda-clears-roche-and-eli-lillys-alzheimers-blood-test\/\" rel=\"noopener noreferrer nofollow\" target=\"_blank\">Forbes.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Topline The Food and Drug Administration has cleared a new blood test from Roche and Eli Lilly designed&hellip;\n","protected":false},"author":2,"featured_media":119893,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[124],"tags":[15909,14442,58496,216,134,15704],"class_list":["post-119892","post","type-post","status-publish","format-standard","has-post-thumbnail","category-roche","tag-alzheimers-disease","tag-blood-test","tag-blood-testing","tag-eli-lilly","tag-roche","tag-test"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ch\/117151771346185955","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/119892","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=119892"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/119892\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media\/119893"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media?parent=119892"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/categories?post=119892"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/tags?post=119892"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}