{"id":3401,"date":"2025-05-23T12:16:17","date_gmt":"2025-05-23T17:16:17","guid":{"rendered":"https:\/\/claremontcoloniccenter.com\/?p=3401"},"modified":"2025-05-23T12:44:15","modified_gmt":"2025-05-23T17:44:15","slug":"fda-greenlights-first-blood-test-to-help-diagnose-alzheimers-disease-in-the-us","status":"publish","type":"post","link":"https:\/\/claremontcoloniccenter.com\/?p=3401","title":{"rendered":"FDA Greenlights First Blood Test to Help Diagnose Alzheimer\u2019s Disease in the US"},"content":{"rendered":"\t\t
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FDA Greenlights First Blood Test to Help Diagnose Alzheimer\u2019s Disease in the US<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\tThe US Food and Drug Administration has given marketing clearance to a blood test to help diagnose Alzheimer\u2019s disease, making the test the first to get signoff to aid in the early detection of the disease in the United States.<\/i><\/b>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\tThe test, called the Lumipulse G pTau217\/\u00df-Amyloid 1-42 Plasma Ratio, is for adults 55 and older who are showing signs and symptoms of Alzheimer\u2019s disease, the FDA announced Friday.

\n\nIt works by measuring two proteins in blood plasma: pTau217 and beta-amyloid 1-42. A ratio of those proteins tends to correlate with the occurrence or absence of amyloid plaques in the brain, which are among the hallmarks of Alzheimer\u2019s disease. The test does not measure amyloid directly but can signal its presence.

\n\nHowever, there remains no current single test to diagnose Alzheimer\u2019s disease. Doctors primarily rely on a variety of tools to diagnose the condition, which may include medical history, neurological exams, cognitive and functional evaluations, brain imaging, spinal fluid analysis and, more recently, blood tests.

\n\nThe FDA said the results of the newly cleared blood test must be assessed in conjunction with other clinical information from a patient.

\n\n\u201cAlzheimer\u2019s disease impacts too many people, more than breast cancer and prostate cancer combined,\u201d FDA Commissioner Dr. Martin Makary said in Friday\u2019s announcement. \u201cKnowing that 10% of people aged 65 and older have Alzheimer\u2019s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.\u201d

\n\nAccording to the FDA, the new blood test \u2013 developed by the Pennsylvania-based biotechnology company Fujirebio Diagnostics Inc. \u2013 can help increase access to Alzheimer\u2019s disease detection and reduce reliance on positron emission tomography or PET scans, a type of imaging that can reveal amyloid plaques in the brain but can be expensive, costing thousands of dollars without insurance.

\n\nThe FDA said it reviewed clinical trial data on the new blood test, involving plasma samples collected from 499 adults who were cognitively impaired. The samples were evaluated using the blood test, and the results were compared with the results from patients\u2019 PET scans or separate testing using cerebrospinal fluid samples, such as from spinal taps.

\n\nThe data showed that 91.7% of adults with positive results using the blood test had the presence of amyloid plaques confirmed by their PET scan or cerebrospinal fluid test, and 97.3% of people with negative results had a negative amyloid PET scan or cerebrospinal fluid test result, according to the FDA.

\n\nThe agency added that the risks associated with the blood test are mainly the risk of a false positive or false negative test result.

\n\nA \u2018new era\u2019 of Alzheimer\u2019s research<\/b>

\n\nPreventive neurologist Dr. Richard Isaacson, who established one of the first Alzheimer\u2019s prevention clinics in the United States, said he has been using this blood test for years for research and applauded the FDA clearance.

\n\n\u201cIt can provide better clarity into whether a person experiencing memory loss may have Alzheimer\u2019s disease. They can take this test as a screening test,\u201d said Isaacson, director of research at the Institute for Neurodegenerative Diseases in Florida. Compared with costly PET scans or spinal taps, \u201cthis is a much more simple screening test, with reasonable accuracy, to tell the physician that a person with cognitive decline has symptoms that are actually due to Alzheimer\u2019s disease.\u201d

\n\nBut Isaacson warned that while the FDA clearance is \u201can important step forward\u201d for the field, more research is needed to help inform how blood test results should be interpreted and used to make clinical decisions.

\n\n\u201cI think the next step as a field is, we need to advance education about what these tests mean and what they don\u2019t and who they should be used for,\u201d he said. \u201cBecause they mean different things in different people depending on their risk factors and whether or not they have symptoms. So we\u2019re still early.\u201d

\n\nFujirebio Diagnostics designed the blood test to help detect Alzheimer\u2019s disease early, when interventions are more effective, president and CEO Monte Wiltse said in a news release last year, when the company filed its test with the FDA.

\n\n\u201cAn early and accurate diagnosis will also facilitate the development of new drug therapies, which are urgently needed as the prevalence of AD increases with a rapidly aging population globally,\u201d Wiltse said.

\n\nIt\u2019s estimated that more than 2 in 5 people over the age of 55 in the United States \u2013 about 42% \u2013 will develop dementia in their later years.

\n\nBut in some cases, deposits of amyloid can start to accumulate in the brain decades before Alzheimer\u2019s symptoms begin. Early detection of these amyloid plaques could open the door for a person to take steps to slow the progression of disease, such as starting preventive treatment with medications.

\n\n\u201cFor too long Americans have struggled to get a simple and accurate diagnosis, with today\u2019s action by the FDA we are hopeful it will be easier for more individuals to receive an accurate diagnosis earlier,\u201d Dr. Maria Carrillo, chief science officer and medical affairs lead at the Alzheimer\u2019s Association, said in a statement Friday.

\n\nThere are a variety of laboratory-developed tests on the market that can be used to detect blood-based biomarkers associated with Alzheimer\u2019s, according to the Alzheimer\u2019s Association, as well as experimental tests. But the Fujirebio Diagnostics test is the first one cleared by the FDA.

\n\n\u201cBlood-based biomarkers are reshaping how we identify and understand Alzheimer\u2019s disease,\u201d Carrillo said. \u201cAt the same time, there are important questions for health care professionals to consider; in particular, who should be tested and when.\u201d

\n\nFor now, the FDA\u2019s clearance \u201cmarks a major milestone,\u201d said Dr. Howard Fillit, co-founder and chief science officer at the Alzheimer\u2019s Drug Discovery Foundation.

\n\n\u201cThe ability to diagnose Alzheimer\u2019s earlier with a simple blood test, like we do for cholesterol, is a game changer, allowing more patients to receive treatment options that have the potential to significantly slow or even prevent the disease,\u201d Fillit said in an email Friday. \u201cThis is a clear example of the new era of Alzheimer\u2019s research where innovation, science and technology come together to develop more accessible, affordable and scalable tools that will pave the way for additional regulatory approvals of diagnostic tools.\u201d

\n\n\nContributor: Jacqueline Howard \u2013 CNN Health<\/i>\n\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

FDA Greenlights First Blood Test to Help Diagnose Alzheimer\u2019s Disease in the US The US Food and Drug Administration has given marketing clearance to a blood test to help diagnose Alzheimer\u2019s disease, making the test the first to get signoff to aid in the early detection of the disease in the United States. The test, […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7,4,5],"tags":[],"class_list":["post-3401","post","type-post","status-publish","format-standard","hentry","category-health","category-lifestyle","category-nutrition"],"_links":{"self":[{"href":"https:\/\/claremontcoloniccenter.com\/index.php?rest_route=\/wp\/v2\/posts\/3401","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/claremontcoloniccenter.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/claremontcoloniccenter.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/claremontcoloniccenter.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/claremontcoloniccenter.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3401"}],"version-history":[{"count":4,"href":"https:\/\/claremontcoloniccenter.com\/index.php?rest_route=\/wp\/v2\/posts\/3401\/revisions"}],"predecessor-version":[{"id":3406,"href":"https:\/\/claremontcoloniccenter.com\/index.php?rest_route=\/wp\/v2\/posts\/3401\/revisions\/3406"}],"wp:attachment":[{"href":"https:\/\/claremontcoloniccenter.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3401"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/claremontcoloniccenter.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3401"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/claremontcoloniccenter.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3401"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}