ZURICH, May 12 (Reuters) – Swiss drugmaker Roche has received the CE mark – a \u200cEuropean regulatory clearance allowing sale in \u200cthe region – for its second Elecsys blood test for \u200bAlzheimer’s disease, it said on Tuesday. <\/p>\n
The test was developed with U.S. company Eli Lilly. <\/p>\n
\u2022 Compared with its already approved pTau181 test, \u200cwhich mainly helps \u2060rule out Alzheimer’s-related amyloid pathology, the newer pTau217 test can both \u2060help confirm and exclude the disease. It is validated for use in both primary \u200band specialist \u200bcare. <\/p>\n
\u2022 The test \u200bhas already received breakthrough \u200cdevice designation from the U.S. FDA. <\/p>\n
\u2022 Blood tests could speed diagnosis and widen access to treatments such as Biogen and Eisai’s Leqembi and Eli Lilly’s Kisunla, as current \u200cdiagnostic methods are often \u200bcostly or uncomfortable. <\/p>\n
\u2022 Roche \u200bsaid an estimated \u200b75% of people living with \u200cdementia remain undiagnosed. <\/p>\n
\u2022 The test \u200bis expected \u200bto become available in CE-marked markets from July, Olivier Gillieron, life cycle leader \u200bin cardiometabolic \u200cand neurology at Roche told media \u200bin a call. <\/p>\n
(Reporting by Marleen Kaesebier. \u200bEditing by Mark Potter) <\/p>\n","protected":false},"excerpt":{"rendered":"ZURICH, May 12 (Reuters) – Swiss drugmaker Roche has received the CE mark – a \u200cEuropean regulatory clearance…\n","protected":false},"author":2,"featured_media":112399,"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-112398","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\/117049204873530403","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/112398","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=112398"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/112398\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media\/112399"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media?parent=112398"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/categories?post=112398"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/tags?post=112398"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}