{"id":671219,"date":"2026-09-03T23:08:19","date_gmt":"2026-09-03T23:08:19","guid":{"rendered":"https:\/\/www.europesays.com\/ie\/671219\/"},"modified":"2026-09-03T23:08:19","modified_gmt":"2026-09-03T23:08:19","slug":"fda-approves-new-alzheimers-blood-test-that-family-doctors-can-order","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ie\/671219\/","title":{"rendered":"FDA approves new Alzheimer\u2019s blood test that family doctors can order"},"content":{"rendered":"

FDA approves new Alzheimer\u2019s blood test for people over 55. Here\u2019s what it can \u2014 and can\u2019t \u2014 tell<\/p>\n

It\u2019s more accessible, for starters. <\/p>\n

\"Korin\"Default<\/p>\n

It used to be that doctors couldn\u2019t diagnose patients with Alzheimer\u2019s disease until after they had died. But new tests have made it possible to figure out what\u2019s driving a person\u2019s cognitive decline while they\u2019re still alive, including a blood test.<\/p>\n

Now, the Food and Drug Administration (FDA) has approved another blood test to test for Alzheimer\u2019s disease.<\/p>\n

It\u2019s called Elecsys pTau217, and it\u2019s a blood biomarker test that can help doctors ID patients in primary care and specialty care who are unlikely or likely to have Alzheimer\u2019s-related brain changes. That means your primary care physician could order this test, along with neurologists, making it accessible to more healthcare providers.<\/p>\n

While that sounds good in theory, doctors say there are pros and cons to this level of accessibility. Here\u2019s why. <\/p>\n

What is the new Alzheimer\u2019s blood test?<\/strong><\/p>\n

Elecsys pTau217 is a blood test from Roche that can be used to rule in or rule out the presence of amyloid plaques, which are hallmarks of Alzheimer\u2019s disease, per a press release<\/a> from Roche. The test is designed for people aged 55 and up who have signs, symptoms, or complaints of cognitive decline.<\/p>\n

The test results are designed to be used \u201cin conjunction with clinical information and other relevant findings\u201d to help diagnose or rule out Alzheimer\u2019s disease in patients, according to Roche.<\/p>\n

\u201cCurrently, many patients face prolonged uncertainty because traditional dementia diagnostics like brain scans and spinal taps are prohibitively expensive, physically invasive, and restricted to specialized medical centers,\u201d says Manisha Parulekar, division chief of geriatrics and co-director of the Center for Memory Loss and Brain Health at Hackensack Meridian Health. \u201cBlood biomarkers offer a transformative alternative.\u201d <\/p>\n

These tests are usually accessible, affordable, and accurate, and can give patients and their families answers without pain or high costs. (Roche hasn\u2019t yet publicly revealed how much the test will cost.)<\/p>\n

\u201cThis breakthrough allows families to find direction, reducing the anxiety of the unknown so that targeted care can begin,\u201d Parulekar says.<\/p>\n

How is it different from the existing Alzheimer\u2019s blood test?<\/strong><\/p>\n

There is already a blood test for Alzheimer\u2019s disease available, called Lumipulse. But the test requires visiting a specialty lab and is a little more complicated than the latest offering. <\/p>\n

\u201cBlood tests for Alzheimer\u2019s already exist, but many combine multiple measurements\u2014for example, pTau217 with amyloid-beta \u2014 and interpret them as a ratio,\u201d explains Davide Cappon, director of neuropsychology at Tufts Medical Center. \u201cThis measures pTau217 alone.\u201d<\/p>\n

In practical terms, a low result means amyloid in the brain is unlikely, while a high result makes it much more likely, he explains. \u201cImportantly, [the test is] just ruling in or out related brain pathology, not making a diagnosis based on a blood test alone,\u201d Cappon says.<\/p>\n

Because it\u2019s designed to run on widely available lab instruments, clinics and hospitals can use their existing diagnostic tools, she points out. That makes accurate Alzheimer\u2019s assessments accessible, even in primary care settings, Parulekar says.<\/p>\n

But Clifford Segil, a neurologist at Providence Saint John’s Health Center in Santa Monica, California, has concerns about anyone being able to order this test. <\/p>\n

\u201cThis is quite scary, as the doctor ordering a test should know how to interpret a positive or negative result,\u201d he says. <\/p>\n

Segil points out that the value of blood tests to determine Alzheimer\u2019s disease \u201cremains debatable\u201d with neurologists, given that the disease can be complicated to diagnose. <\/p>\n

\u201cPrimary care doctors who obtain this test will not know how to counsel patients on the meaning of a positive or negative result,\u201d Segil says.<\/p>\n

Who is a candidate for this blood test?<\/strong><\/p>\n

Anyone over the age of 55 with signs and symptoms of Alzheimer\u2019s disease can receive the test.<\/p>\n

\u201cThe biology of Alzheimer\u2019s can start years before symptoms, so yes, a blood biomarker can become abnormal before someone develops obvious memory problems,\u201d Cappon says. \u201cBut that does not mean we should test everyone who feels well. This test is intended for people who already have cognitive symptoms or concerns.\u201d<\/p>\n

Cappon points out that more people without symptoms are asking for these tests. <\/p>\n

\u201cIf someone is cognitively normal and the biomarker comes back positive, we cannot yet tell them with certainty whether they will develop symptoms\u2014or when,\u201d he says. \u201cSo in someone without cognitive concerns, I think we still need to be very thoughtful about what question we are trying to answer and what we would actually do with the result.\u201d<\/p>\n

Do you still need to have symptoms to be diagnosed?<\/strong><\/p>\n

Yes, you still need to have symptoms like memory loss. <\/p>\n

\u201cThe pTau217 test is not a screening tool for healthy individuals; it requires clinical context,\u201d Parulekar says. \u201cWhen people experience cognitive decline and report complaints, doctors can use this blood test to supplement their evidence.\u201d<\/p>\n

Even if the biomarker test is positive, your doctor will still need to incorporate their evaluation into the diagnosis. <\/p>\n

\u201cA definitive Alzheimer’s diagnosis will always incorporate a doctor’s evaluation of the patient’s actual, observable symptoms alongside the lab results,\u201d Parulekar says.<\/p>\n","protected":false},"excerpt":{"rendered":"FDA approves new Alzheimer\u2019s blood test for people over 55. Here\u2019s what it can \u2014 and can\u2019t \u2014…\n","protected":false},"author":2,"featured_media":671220,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[275],"tags":[9288,5194,283625,283626,122984,15596,283629,34756,283633,5195,5960,685,18,283628,283631,2898,135,475,474,19,17,231428,283632,283630,1595,237,26571,283627,202961,72176,35435],"class_list":["post-671219","post","type-post","status-publish","format-standard","has-post-thumbnail","category-healthcare","tag-alzheimer","tag-alzheimers","tag-alzheimers-blood-test","tag-alzheimers-test","tag-amyloid-plaques","tag-biomarker","tag-blood-biomarker","tag-blood-test","tag-clifford-segil","tag-cognitive-decline","tag-diagnosis","tag-disease","tag-eire","tag-elecsys-ptau217","tag-family-doctor","tag-fda","tag-health","tag-health-care","tag-healthcare","tag-ie","tag-ireland","tag-ldnd","tag-manisha-parulekar","tag-new-test","tag-patient","tag-people","tag-physician","tag-primary-care-doctor","tag-ptau217","tag-roche","tag-symptom"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ie\/117209629257955876","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/671219","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/comments?post=671219"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/671219\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media\/671220"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media?parent=671219"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/categories?post=671219"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/tags?post=671219"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}