Labcorp to Offer First FDA-Cleared Blood Test to Rule out Alzheimer's-Related Amyloid Pathology in Primary Care Settings
Labcorp (NYSE: LH) will offer Roche's FDA-cleared Elecsys pTau181 blood test nationwide by early 2026 to aid initial assessment of Alzheimer's-related amyloid pathology in primary care. The test is intended for adults 55+ with cognitive complaints and measures plasma phosphorylated Tau 181. Roche reported a 97.9% negative predictive value (NPV), meaning a negative result aligns with a negative amyloid PET and lowers the likelihood that cognitive impairment is due to amyloid pathology. Testing can be performed at a clinician's office or at any of Labcorp's >2,200 patient service centers.
Labcorp (NYSE: LH) offrirà a livello nazionale entro l'inizio del 2026 il test del sangue Elecsys pTau181 di Roche, approvato dalla FDA, per supportare una valutazione iniziale della patologia amiloide associata all'Alzheimer nella medicina generale. Il test è destinato ad adulti di 55 anni o più con lamentele cognitive e misura la Tau fosforilata 181 nel plasma. Roche ha riportato un valore predittivo negativo (NPV) del 97,9%, il che significa che un risultato negativo corrisponde a una PET amiloide negativa e riduce la probabilità che il deterioramento cognitivo sia dovuto alla patologia amiloide. I test possono essere eseguiti presso lo studio del medico o in uno dei >2.200 centri di servizio per i pazienti di Labcorp.
Labcorp (NYSE: LH) ofrecerá en todo el país, a principios de 2026, la prueba de sangre Elecsys pTau181 de Roche, aprobada por la FDA, para ayudar a la evaluación inicial de la patología amiloide relacionada con la enfermedad de Alzheimer en atención primaria. La prueba está destinada a adultos de 55 años o más con quejas cognitivas y mide la Tau fosforilada 181 en plasma. Roche informó de un valor predictivo negativo (VPN) del 97,9%, lo que significa que un resultado negativo coincide con una PET amiloide negativa y reduce la probabilidad de que el deterioro cognitivo se deba a la patología amiloide. Las pruebas pueden realizarse en la consulta del médico o en cualquiera de los más de 2.200 centros de servicio al paciente de Labcorp.
Labcorp (NYSE: LH)는 Roche의 FDA‑승인 Elecsys pTau181 혈액 검사를 2026년 초까지 전국적으로 제공하여 1차 진료에서 알츠하이머와 관련된 아밀로이드 병리를 초기 평가하는 데 도움을 줄 것입니다. 이 테스트는 55세 이상 인지 증상을 가진 성인을 대상으로 하며 혈장 인산화 타우 181을 측정합니다. Roche는 NPV 97.9%를 보고했는데, 이는 음성 결과가 음성 아밀로이드 PET와 일치하고 인지 기능 저하가 아밀로이드 병리로 인한 것일 확률을 낮춘다는 것을 의미합니다. 검사는 의사 진료실이나 Labcorp의 2,200개가 넘는 환자 서비스 센터 중 어느 곳에서나 실시할 수 있습니다.
Labcorp (NYSE: LH) proposera, d'ici le début de 2026, le test sanguin Elecsys pTau181 de Roche, approuvé par la FDA, à l'échelle nationale pour aider à l'évaluation initiale de la pathologie amyloïde liée à la maladie d'Alzheimer en soins primaires. Le test est destiné aux adultes de 55 ans et plus présentant des plaintes cognitives et mesure la Tau phosphorylée 181 dans le plasma. Roche a rapporté une valeur prédictive négative (VPN) de 97,9%, ce qui signifie qu'un résultat négatif est aligné avec un PET amyloïde négatif et réduit la probabilité que le déclin cognitif soit dû à une pathologie amyloïde. Les tests peuvent être réalisés au cabinet d'un médecin ou dans l'un des plus de 2 200 centres de service aux patients de Labcorp.
Labcorp (NYSE: LH) wird Roche's von der FDA bestätigten Elecsys pTau181 Blutt-Test bis Anfang 2026 landesweit anbieten, um bei der Erstbewertung einer Alzheimer-bezogenen Amyloidpathologie in der Primärversorgung zu helfen. Der Test ist für Erwachsene ab 55 Jahren mit kognitiven Beschwerden gedacht und misst Plasma-phosphoryliertes Tau 181. Roche berichtete von einem NPV von 97,9%, was bedeutet, dass ein negatives Ergebnis mit einer negativen Amyloid-PET übereinstimmt und die Wahrscheinlichkeit verringert, dass kognitiver Abbau auf eine Amyloidpathologie zurückzuführen ist. Die Tests können in der Praxis eines Arztes oder in einem der Labcorp‑Patientenservicezentren mit mehr als 2.200 Standorten durchgeführt werden.
Labcorp (NYSE: LH) ستوفر الاختبار الدموي Elecsys pTau181 من Roche والمعتمد من FDA على مستوى البلاد بحلول أوائل 2026 للمساعدة في التقييم الأولي لباثولوجيا الأميلويد المرتبطة بمرض الزهايمر في الرعاية الأولية. الاختبار مخصص للبالغين 55 عامًا وفوق مع شكاوى إدراكية ويقيس Tau-181 الفسفورية في البلازما. روشي أبلغت عن قيمة تنبؤية سلبية (NPV) تبلغ 97.9%، مما يعني أن نتيجة سلبية تتماشى مع تصوير PET الأميلويد سلبياً وتخفض احتمال أن يكون العطب الإدراكي بسبب باثولوجيا أميلويد. يمكن إجراء الاختبار في عيادة الطبيب أو في أي من مراكز خدمة المرضى التابعة لـ Labcorp والتي يزيد عددها عن 2,200.
Labcorp (NYSE: LH) 将在2026年初前通过全国范围提供 Roche 的 FDA 批准的 Elecsys pTau181 血液测试，以帮助在初级保健中对与阿尔茀海默病相关的淀粉样病变进行初步评估。该测试适用于55岁及以上、有认知能力下降的成年人，测量血浆中的磷酸化 Tau 181。罗氏报告的< b>97.9%的阴性预测值（NPV），这意味着阴性结果与阴性淀粉样蛋白 PET 相符，并降低认知障碍是因淀粉样病变引起的可能性。检测可以在医生诊所进行，也可以在 Labcorp 的超过 2,200 个患者服务中心中的任意一个进行。
- FDA-cleared test for Alzheimer's-related amyloid pathology
- Plasma pTau181 shows a 97.9% negative predictive value
- Nationwide availability planned by early 2026
- Accessible via >2,200 Labcorp patient service centers
- Test intended only for adults age 55 and older
- Positive results require further confirmatory evaluation
- Positioned for initial assessment, not definitive diagnosis
Insights
Labcorp will expand primary‑care access to the only FDA‑cleared blood test that helps rule out Alzheimer’s amyloid pathology.
The Elecsys pTau181 assay measures phosphorylated Tau 181 in plasma and reports a
The main dependencies are clinician adoption and diagnostic pathways: primary‑care clinicians must order the test, interpret a negative result as reason to investigate other causes, and follow up positives with further specialty evaluation. Reimbursement and clear reporting guidance will shape uptake; the
Making an FDA‑cleared blood test available nationwide should improve access and could shift diagnostic workflows toward earlier, less invasive screening.
By offering a cleared assay developed by Roche across its network, Labcorp removes a specialist and procedure barrier for many patients, enabling primary‑care clinicians to rule out amyloid pathology quickly. The convenience of in‑office draws and >2,200 PSCs lowers logistical friction compared with PET or lumbar puncture and likely increases the addressable test volume in routine care.
Key risks to commercial impact include payer coverage, clinician education on test interpretation, and follow‑up capacity in neurology. Important near‑term milestones are availability nationwide by
Labcorp plans to make Roche's Elecsys® pTau181 test available nationwide by early 2026
An estimated 7.2 million Americans are living with Alzheimer's disease, a number expected to nearly double by 2050. Cognitive changes are often first identified during routine care visits, but Alzheimer's biomarker testing has traditionally required a specialist referral and advanced invasive testing. The Elecsys pTau181 test is intended for adults ages 55 and older with signs, symptoms or complaints of cognitive decline. Clinicians can order the test to help rule out Alzheimer's-related amyloid pathology and identify patients who may benefit from further evaluation.
"Many patients presenting with cognitive symptoms don't have Alzheimer's disease, so helping clinicians rule it out can be just as critical as confirming it," said Dr. Brian Caveney, chief medical and scientific officer at Labcorp. "As a leader in neurology with the broadest portfolio of Alzheimer's tests, Labcorp is proud to make the FDA-cleared Elecsys pTau181 test widely available—helping physicians identify the causes of cognitive decline and guide timely, appropriate care."
Key Features of the Elecsys pTau181 Test
The Elecsys pTau181 test measures phosphorylated Tau (pTau) 181 protein in human plasma, a key biomarker for Alzheimer's pathology, including amyloid plaque and tau aggregate pathology. According to Roche, clinical results demonstrated the test could rule out Alzheimer's pathology with a
Performed via a simple blood draw, the test offers an accessible, more affordable and less invasive alternative to traditional tests such as cerebrospinal fluid (CSF) testing obtained through lumbar puncture and PET scans. Once the test is ordered, the blood draw can be completed in a doctor's office or at any of Labcorp's more than 2,200 patient service centers (PSCs) nationwide.
A Leader in Alzheimer's Testing
Labcorp's announcement underscores the company's commitment to expanding access to blood-based biomarkers for Alzheimer's disease testing. Since March 2023, Labcorp has offered a laboratory-developed test (LDT) version of pTau181, and in October 2023, added it to the company's ATN Profile — a panel combining three key biomarkers to identify and assess biological changes associated with Alzheimer's disease. Most recently, Labcorp launched the FDA-cleared Lumipulse® pTau-217/Beta Amyloid 42 Ratio to aid in the diagnosis of Alzheimer's disease for use in specialty care settings.
For more information about Labcorp's portfolio of tests, visit https://www.labcorp.com/treatment-areas/neurology/conditions/neurodegenerative/alzheimers
About Labcorp
Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's nearly 70,000 employees serve clients in approximately 100 countries, provided support for more than
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements with respect to the expected utility of and benefits to clinicians and patients of the Elecsys pTau181 test.
Each of the forward-looking statements is subject to change based on various important factors, many of which are beyond the company's control. These factors, in some cases, have affected and in the future (together with other factors) could affect the company's ability to implement the company's business strategy, and actual results could differ materially from those suggested by these forward-looking statements. As a result, readers are cautioned not to place undue reliance on any of the forward-looking statements.
The company has no obligation to provide any updates to these forward-looking statements even if its expectations change. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Further information on potential factors, risks and uncertainties that could affect operating and financial results is included in the company's most recent Annual Report on Form 10-K under the heading RISK FACTORS and in the company's other filings with the SEC. The information in this press release should be read in conjunction with a review of the company's filings with the SEC including the information in the company's most recent Annual Report on Form 10-K under the heading "MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS".
View original content to download multimedia:https://www.prnewswire.com/news-releases/labcorp-to-offer-first-fda-cleared-blood-test-to-rule-out-alzheimers-related-amyloid-pathology-in-primary-care-settings-302592423.html
SOURCE Labcorp
FAQ
When will Labcorp (LH) offer the Roche Elecsys pTau181 test nationwide?
What does the Elecsys pTau181 result mean for LH patients aged 55+?
Where can clinicians have the Elecsys pTau181 blood draw performed through Labcorp (LH)?
Is the Elecsys pTau181 test a definitive Alzheimer's diagnosis for LH patients?
Which patients are eligible for the Elecsys pTau181 test offered by Labcorp (LH)?
