Topline<\/p>\n
The Food and Drug Administration has cleared a new blood test from Roche and Eli Lilly designed to help identify symptoms related to Alzheimer\u2019s disease in patients over age 55, Roche said on Monday morning.<\/p>\n
The FDA cleared the new blood test on Monday, Roche and Eli Lilly said in a statement.<\/p>\n
Getty ImagesKey Facts<\/p>\n
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\u2019s disease.<\/p>\n
Doctors could previously diagnose amyloid pathology using PET imaging or cerebrospinal fluid testing\u2014both expensive and invasive procedures.The test was designed to be \u201cminimally invasive\u201d and to work easily beside \u201cexisting laboratory workflows,\u201d Roche and Lilly said, and won\u2019t require labs to purchase additional equipment.<\/p>\n
However, the test was not designed to be a standalone test for Alzheimer\u2019s and should be interpreted for patients with other clinical information.<\/p>\n
Both Labcorp and Quest Diagnostics, two large companies that offer blood testing services, said they planned to start offering the new test.<\/p>\n
Key Background<\/p>\n
The FDA previously cleared the first blood test<\/a> for Alzheimer\u2019s last May. That test, developed by Japanese biotech firm Fujirebio, also tests for amyloid plaques in plasma and can be used to \u201creliably predict\u201d amyloid pathology.<\/p>\n Big Number<\/p>\n 6.7 million. That\u2019s how many older adults are living with diagnosed Alzheimer\u2019s disease in the U.S., according to the 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\u2019s could be much higher. Research published by Alzheimer\u2019s Disease International<\/a> in 2021 found 55 million people across the world suffer from dementia, but about 75% of cases remain undiagnosed.<\/p>\n","protected":false},"excerpt":{"rendered":"Topline The Food and Drug Administration has cleared a new blood test from Roche and Eli Lilly designed…\n","protected":false},"author":2,"featured_media":69884,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[4],"tags":[23043,36199,8293,2113,8,9,36198,7],"class_list":["post-69883","post","type-post","status-publish","format-standard","has-post-thumbnail","category-top-stories","tag-alzheimers-disease","tag-blood-testing","tag-eli-lilly","tag-fda","tag-headlines","tag-news","tag-roche","tag-top-stories"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@news\/117152443441216049","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/posts\/69883","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/comments?post=69883"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/posts\/69883\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/media\/69884"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/media?parent=69883"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/categories?post=69883"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/news\/wp-json\/wp\/v2\/tags?post=69883"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}