{"id":10432,"date":"2025-10-19T16:38:32","date_gmt":"2025-10-19T23:38:32","guid":{"rendered":"https:\/\/www.telemedical.com\/wordpress\/?page_id=10432"},"modified":"2025-11-06T15:38:35","modified_gmt":"2025-11-06T23:38:35","slug":"ptau219-lab-tests","status":"publish","type":"page","link":"https:\/\/www.telemedical.com\/wordpress\/home\/alzheimers\/blood-ptau-217-testing\/ptau219-lab-tests\/","title":{"rendered":"pTau217 Lab tests"},"content":{"rendered":"\n<p>Other Laboratories<\/p>\n\n\n\n<p><strong>Quanterix \/ Lucent Diagnostics<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Their LucentAD\u00ae product line includes a high-accuracy p-Tau 217 blood test for Alzheimer\u2019s diagnosis, leveraging the ultra-sensitive Simoa\u00ae technology and specialized antibodies.<a href=\"https:\/\/www.quanterix.com\/press-releases\/quanterix-launches-high-accuracy-p-tau-217-blood-biomarker-test-to-aid-physician-diagnosis-of-alzheimers-disease\/\" target=\"_blank\" rel=\"noreferrer noopener\"><\/a><\/li>\n\n\n\n<li>This test has been clinically validated and is available through licensed medical providers. see <a href=\"https:\/\/lucent.dxresults.com\/\">https:\/\/lucent.dxresults.com\/<\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>2. ARUP Laboratories<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ARUP now offers a pTau217 blood test, validated with samples from major clinical trials. The test is performed on Quanterix\u2019s Simoa platform using antibody technology licensed from Eli Lilly.<a href=\"https:\/\/www.aruplab.com\/news\/04-21-2025\/arup-launches-ptau-217-test-detect-alzheimers-disease\" target=\"_blank\" rel=\"noreferrer noopener\"><\/a><\/li>\n\n\n\n<li>ARUP is recognized for integrating recent research biomarkers into clinical diagnostics.<\/li>\n<\/ul>\n\n\n\n<p><strong>3. Roche Diagnostics<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Roche, in partnership with Eli Lilly, is developing the Elecsys\u00ae pTau217 plasma biomarker test. It has received FDA Breakthrough Device Designation and is in advanced stages of regulatory clearance in the U.S. and Europe.<a href=\"https:\/\/diagnostics.roche.com\/us\/en\/news-listing\/2024\/roche-granted-fda-breakthrough-device-designation-ptau217-blood-test-support-earlier-alzheimers-disease-diagnosis.html\" target=\"_blank\" rel=\"noreferrer noopener\"><\/a><\/li>\n\n\n\n<li>Roche is a global leader in clinical diagnostics with broad implementation capabilities.<\/li>\n<\/ul>\n\n\n\n<p><strong>4. <a href=\"https:\/\/www.fujirebio.com\/en-us\/Alzheimer\">Fujirebio<\/a> -used by Labcorp and others<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Makers of Lumipulse\u00ae G pTau 217\/\u03b2-Amyloid 1-42 Plasma Ratio test, which recently received marketing clearance from the FDA for early detection of amyloid plaques in Alzheimer\u2019s disease.<a href=\"https:\/\/www.fujirebio.com\/en-us\/news-events\/fujirebio-receives-marketing-clearance-for-lumipulser-g-ptau-217bamyloid-142-plasma-0\" target=\"_blank\" rel=\"noreferrer noopener\"><\/a><\/li>\n\n\n\n<li>Fujirebio is collaborating with Biogen and Beckman Coulter to advance blood-based tau pathology diagnostics.<a href=\"https:\/\/www.fujirebio.com\/en-us\/Alzheimer\" target=\"_blank\" rel=\"noreferrer noopener\"><\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>5. <a href=\"https:\/\/www.questdiagnostics.com\/healthcare-professionals\/about-our-tests\/neurological-disorders\/alzheimers\">Quest Diagnostics<\/a><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Their AD-Detect\u2122 suite now offers p-tau217 plasma biomarker blood testing for Alzheimer\u2019s disease risk assessment, available via physician order at nationwide service centers.<a href=\"https:\/\/newsroom.questdiagnostics.com\/2024-04-22-Quest-Diagnostics-Adds-p-tau217-Blood-Biomarker-Testing-to-Suite-of-Services-Designed-to-Assess-Risk-and-Help-Aid-Diagnosis-of-Alzheimers-Disease\" target=\"_blank\" rel=\"noreferrer noopener\"><\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>6. <a href=\"https:\/\/alzpath.bio\/global-momentum-and-validation-grows-at-aaic-for-alzpath-proprietary-ptau217-antibody-use-in-alzheimers-disease-research-diagnosis-and-treatment\/\">ALZpath<\/a><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ALZpath specializes in early Alzheimer\u2019s blood biomarkers and has developed proprietary pTau217 antibodies that are licensed to other diagnostic labs and companies. Direct testing branded as ALZpath Dx is also available, supporting both research and clinical deployment.<a href=\"https:\/\/alzpath.bio\/\" target=\"_blank\" rel=\"noreferrer noopener\"><\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>8. Mayo Clinic Laboratories<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Mayo Clinic provides a blood (plasma) pTau217 test as part of its clinical diagnostic catalog for Alzheimer\u2019s evaluation.<a href=\"https:\/\/www.mayocliniclabs.com\/test-catalog\/Overview\/621635\" target=\"_blank\" rel=\"noreferrer noopener\"><\/a><\/li>\n<\/ul>\n\n\n\n<p><strong>9. <a href=\"https:\/\/precivityad.com\/precivityad2-hcp\">C2N<\/a> Precivity AD2 -Blood Mass Spec based analysis<\/strong><\/p>\n\n\n\n<p><strong>10. <a href=\"https:\/\/spear.bio\/blog\/2025\/01\/13\/spear-bio-secures-fda-breakthrough-device-designation-for-its-novel-ptau-217-blood-test-advancing-scalable-solutions-for-early-alzheimers-disease-diagnosis\/\">Spear Bio<\/a><\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Spear Bio has received FDA breakthrough device designation for its novel pTau217 blood test, advancing scalable biomarker solutions for early Alzheimer\u2019s diagnosis.<a href=\"https:\/\/spear.bio\/blog\/2025\/01\/13\/spear-bio-secures-fda-breakthrough-device-designation-for-its-novel-ptau-217-blood-test-advancing-scalable-solutions-for-early-alzheimers-disease-diagnosis\/\" target=\"_blank\" rel=\"noreferrer noopener\"><\/a>  Using a real time highly sensitive, wash free, homogenous PCR readout.<\/li>\n<\/ul>\n\n\n\n<p>These providers use advanced platform technologies and antibody reagents (often licensed from specialist developers like ALZpath and Eli Lilly) to commercialize and scale pTau blood testing for clinical, research, and pharma trial use. The field continues to expand rapidly as blood biomarkers become increasingly integrated into dementia workups for early and accurate detection.<\/p>\n\n\n\n<p><\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><a href=\"https:\/\/www.quanterix.com\/press-releases\/quanterix-launches-high-accuracy-p-tau-217-blood-biomarker-test-to-aid-physician-diagnosis-of-alzheimers-disease\/\">https:\/\/www.quanterix.com\/press-releases\/quanterix-launches-high-accuracy-p-tau-217-blood-biomarker-test-to-aid-physician-diagnosis-of-alzheimers-disease\/<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.lucentdiagnostics.com\/tests\/lucentad-p-tau-217\/\">https:\/\/www.lucentdiagnostics.com\/tests\/lucentad-p-tau-217\/<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.quanterix.com\/breaking-ground-in-alzheimers-diagnosis-simoa-p-tau-217-blood-test-receives-fda-breakthrough-device-designation\/\">https:\/\/www.quanterix.com\/breaking-ground-in-alzheimers-diagnosis-simoa-p-tau-217-blood-test-receives-fda-breakthrough-device-designation\/<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.aruplab.com\/news\/04-21-2025\/arup-launches-ptau-217-test-detect-alzheimers-disease\">https:\/\/www.aruplab.com\/news\/04-21-2025\/arup-launches-ptau-217-test-detect-alzheimers-disease<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/diagnostics.roche.com\/us\/en\/news-listing\/2024\/roche-granted-fda-breakthrough-device-designation-ptau217-blood-test-support-earlier-alzheimers-disease-diagnosis.html\">https:\/\/diagnostics.roche.com\/us\/en\/news-listing\/2024\/roche-granted-fda-breakthrough-device-designation-ptau217-blood-test-support-earlier-alzheimers-disease-diagnosis.html<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.roche.com\/media\/releases\/med-cor-2025-07-23b\">https:\/\/www.roche.com\/media\/releases\/med-cor-2025-07-23b<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/diagnostics.roche.com\/us\/en\/products\/product-category\/neurology\/alzheimers-disease.html\">https:\/\/diagnostics.roche.com\/us\/en\/products\/product-category\/neurology\/alzheimers-disease.html<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.fujirebio.com\/en-us\/news-events\/fujirebio-receives-marketing-clearance-for-lumipulser-g-ptau-217bamyloid-142-plasma-0\">https:\/\/www.fujirebio.com\/en-us\/news-events\/fujirebio-receives-marketing-clearance-for-lumipulser-g-ptau-217bamyloid-142-plasma-0<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease\">https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/newsroom.questdiagnostics.com\/2024-04-22-Quest-Diagnostics-Adds-p-tau217-Blood-Biomarker-Testing-to-Suite-of-Services-Designed-to-Assess-Risk-and-Help-Aid-Diagnosis-of-Alzheimers-Disease\">https:\/\/newsroom.questdiagnostics.com\/2024-04-22-Quest-Diagnostics-Adds-p-tau217-Blood-Biomarker-Testing-to-Suite-of-Services-Designed-to-Assess-Risk-and-Help-Aid-Diagnosis-of-Alzheimers-Disease<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/alzpath.bio\">https:\/\/alzpath.bio<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.brightfocus.org\/resource\/alzheimers-blood-tests-how-do-they-work-and-should-you-request-one\/\">https:\/\/www.brightfocus.org\/resource\/alzheimers-blood-tests-how-do-they-work-and-should-you-request-one\/<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.labcorp.com\/treatment-areas\/neurology\/conditions\/neurodegenerative\/alzheimers\">https:\/\/www.labcorp.com\/treatment-areas\/neurology\/conditions\/neurodegenerative\/alzheimers<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.labcorp.com\/treatment-areas\/neurology\/clinical-testing\/ptau217betaamyloid42ratio\">https:\/\/www.labcorp.com\/treatment-areas\/neurology\/clinical-testing\/ptau217betaamyloid42ratio<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/www.mayocliniclabs.com\/test-catalog\/Overview\/621635\">https:\/\/www.mayocliniclabs.com\/test-catalog\/Overview\/621635<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/spear.bio\/blog\/2025\/01\/13\/spear-bio-secures-fda-breakthrough-device-designation-for-its-novel-ptau-217-blood-test-advancing-scalable-solutions-for-early-alzheimers-disease-diagnosis\/\">https:\/\/spear.bio\/blog\/2025\/01\/13\/spear-bio-secures-fda-breakthrough-device-designation-for-its-novel-ptau-217-blood-test-advancing-scalable-solutions-for-early-alzheimers-disease-diagnosis\/<\/a><\/li>\n<\/ol>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Other Laboratories Quanterix \/ Lucent Diagnostics 2. ARUP Laboratories 3. Roche Diagnostics 4. Fujirebio -used by Labcorp and others 5. Quest Diagnostics 6. ALZpath 8. Mayo Clinic Laboratories 9. C2N Precivity AD2 -Blood Mass Spec based analysis 10. Spear Bio These providers use advanced platform technologies and antibody reagents (often licensed from specialist developers like [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":10103,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-10432","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.telemedical.com\/wordpress\/wp-json\/wp\/v2\/pages\/10432","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.telemedical.com\/wordpress\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.telemedical.com\/wordpress\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.telemedical.com\/wordpress\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.telemedical.com\/wordpress\/wp-json\/wp\/v2\/comments?post=10432"}],"version-history":[{"count":12,"href":"https:\/\/www.telemedical.com\/wordpress\/wp-json\/wp\/v2\/pages\/10432\/revisions"}],"predecessor-version":[{"id":10660,"href":"https:\/\/www.telemedical.com\/wordpress\/wp-json\/wp\/v2\/pages\/10432\/revisions\/10660"}],"up":[{"embeddable":true,"href":"https:\/\/www.telemedical.com\/wordpress\/wp-json\/wp\/v2\/pages\/10103"}],"wp:attachment":[{"href":"https:\/\/www.telemedical.com\/wordpress\/wp-json\/wp\/v2\/media?parent=10432"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}