Roche and Eli Lilly have secured US Food and Drug Administration clearance for a blood test that detects a single biomarker linked to amyloid plaque buildup in the brain, giving clinicians a faster and less invasive way to assess Alzheimer’s disease in patients showing early signs of cognitive decline.<\/p>\n
The Elecsys pTau217 assay, developed by Roche in collaboration with Eli Lilly, is designed for individuals 55 and older who are experiencing symptoms or complaints of cognitive impairment. It measures phosphorylated Tau 217 protein, a hallmark of Alzheimer’s that has been tied to the presence of amyloid pathology. Results are delivered in positive, intermediate, and negative categories, helping physicians gauge the likelihood that a patient has the disease when combined with clinical information and other findings.<\/p>\n
Roche said the test is the first FDA-cleared, single-biomarker blood test supporting both rule-in and rule-out assessment of amyloid pathology across primary and specialty care settings. The clearance follows a European CE mark awarded in May 2026.<\/p>\n
Dan Malarek, president and CEO of Roche Diagnostics North America, called the approval “an important milestone in Alzheimer’s disease diagnosis” and said the test “has the potential to transform how Alzheimer’s is assessed across primary and specialty care.”<\/p>\n
The regulatory nod comes as the Alzheimer’s diagnostics market heats up. Just days earlier, on August 21, the FDA cleared C2N Diagnostics’ Alzheimer’s assessment blood test, which is notable for being the first cleared for use in patients as young as 40. Fujirebio’s Lumipulse became the first blood test authorized to help diagnose Alzheimer’s in the US in May 2025.<\/p>\n
Roche’s latest clearance also builds on its own earlier work in the space. The FDA approved the company’s Elecsys pTau181 test in October 2025, which measures phosphorylated Tau 181 protein levels in plasma. In diagnostics, pTau217 is generally considered superior to pTau181 for detecting amyloid pathology.<\/p>\n
Eli Lilly shares edged higher in Monday’s pre-market session, trading around $1,261, following news of the approval. The Indianapolis-based drugmaker markets Kisunla (donanemab), an Alzheimer’s treatment that won FDA approval in July 2024.<\/p>\n
Jared R. Brosch, a neurologist at Indiana University Health, highlighted the practical advantages of blood-based testing. “While PET imaging and cerebrospinal fluid biomarkers can confirm amyloid pathology in patients with cognitive impairment, these approaches may be costly, invasive and not readily accessible for many patients,” he said in a release. “Advances in blood-based biomarkers have the potential to transform the diagnostic pathway by expanding access to evaluation for Alzheimer’s across a variety of care settings.”<\/p>\n
Growing Market<\/p>\n
The broader Alzheimer’s market is expanding rapidly. GlobalData analysis projects the disease market across eight major markets \u2014 the US, France, Germany, Italy, Spain, the UK, Japan, and China \u2014 will grow at a compound annual growth rate of 21.8% and reach a valuation of $33 billion in 2033.<\/p>\n
Blood-based diagnostics are seen as particularly valuable in primary care settings, where access to PET imaging and specialists may be limited. Gary Zammit, CEO of contract research organization Clinilabs, previously told Medical Device Network that the pTau181 test’s ability to rule out Alzheimer’s could benefit both primary health diagnosis and patient enrollment in clinical trials, which research indicates have a 98% failure rate.<\/p>\n
The Elecsys pTau217 is the second Alzheimer’s test to emerge from the Roche-Lilly collaboration. Last July, the two companies received European approval for their first blood test designed to help rule out Alzheimer’s disease, which detects phosphorylated tau-181 protein. That test also received FDA approval in February.<\/p>\n","protected":false},"excerpt":{"rendered":"Roche and Eli Lilly have secured US Food and Drug Administration clearance for a blood test that detects…\n","protected":false},"author":2,"featured_media":120069,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[124],"tags":[15909,58557,34906,216,4337,58558,2344,58559,134],"class_list":["post-120068","post","type-post","status-publish","format-standard","has-post-thumbnail","category-roche","tag-alzheimers-disease","tag-c2n-diagnostics","tag-elecsys-ptau217","tag-eli-lilly","tag-fda","tag-fujirebio","tag-globaldata","tag-kisunla","tag-roche"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ch\/117154036037263119","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/120068","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=120068"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/120068\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media\/120069"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media?parent=120068"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/categories?post=120068"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/tags?post=120068"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}