Roche's Elecsys® pTau181 becomes the only FDA-cleared blood test for use in primary care to rule out Alzheimer's-related amyloid pathology
Roche (ROG) announced on October 13, 2025 that the FDA cleared its Elecsys pTau181 blood test as the only blood-based biomarker test indicated for use in primary care to help rule out Alzheimer's-related amyloid pathology. The test is for patients aged 55 and older, was developed with Eli Lilly, and showed a 97.9% negative predictive value in a multicenter study of 312 participants reflective of a primary-care population. With > 4,500 Roche instruments already in U.S. labs and recent CE Mark/IVDR certification, Roche says the test can broaden access, improve referrals, and reduce more invasive confirmatory testing such as PET and CSF.
Roche (ROG) ha annunciato il 13 ottobre 2025 che la FDA ha autorizzato il suo esame del sangue Elecsys pTau181 come unico test biomarker basato sul sangue indicato per l'uso nella assistenza primaria per aiutare a escludere la patologia amiloidea correlata al Alzheimer. Il test è destinato a pazienti di età 55 anni e oltre, è stato sviluppato con Eli Lilly e ha mostrato un valore predittivo negativo del 97,9% in uno studio multicentrico su 312 partecipanti rappresentativo di una popolazione di cure primarie. Con oltre 4.500 strumenti Roche già presenti nei laboratori USA e la recente certificazione CE Mark/IVDR, Roche afferma che il test può ampliare l'accesso, migliorare i rinvii e ridurre test di conferma più invasivi come PET e CSF.
Roche (ROG) anunció el 13 de octubre de 2025 que la FDA autorizó su examen de sangre Elecsys pTau181 como el único biomarcador analítico en sangre indicado para uso en atención primaria para ayudar a descartar la patología amiloidea relacionada con el Alzheimer. La prueba es para pacientes de 55 años o más, fue desarrollada con Eli Lilly y mostró un valor predictivo negativo del 97,9% en un estudio multicéntrico de 312 participantes representativo de una población de atención primaria. Con más de 4.500 instrumentos Roche ya en laboratorios de EE. UU. y la reciente certificación CE Mark/IVDR, Roche dice que la prueba puede ampliar el acceso, mejorar las derivaciones y reducir pruebas de confirmación más invasivas como PET y LCR (CSF).
로체(ROG)는 2025년 10월 13일 FDA가 Elecsys pTau181 혈액 검사를 알츠하이머 관련 아밀로이드 병리를 배제하기 위한 혈액 기반 바이오마커 테스트로써 1차 진료에서의 유일한 지표로 승인했다고 발표했습니다. 이 검사는 55세 이상 환자를 대상으로 하며 엘리 릴리와 협력하여 개발되었고, 97.9%의 음성 예측값을 보였으며 이는 312명의 참가자를 포함한 다기관 연구로 1차 진료 인구를 반영합니다. 미국 실험실에 이미 4,500개 이상의 Roche 기기가 있으며 최근 CE Mark/IVDR 인증을 받았으며, 이 검사가 접근성을 넓히고 의뢰를 개선하며 PET 및 CSF와 같은 더 침습적인 확인 검사를 줄일 수 있다고 로체는 말합니다.
Roche (ROG) a annoncé le 13 octobre 2025 que la FDA a autorisé son test sanguin Elecsys pTau181 comme le seul test biomarqueur sanguin indiqué pour une utilisation dans les soins primaires afin d'aider à exclure la pathologie amiloïde liée à la maladie d'Alzheimer. Le test est destiné aux patients âgés de 55 ans et plus, a été développé avec Eli Lilly, et a démontré une valeur prédictive négative de 97,9% dans une étude multicentrique portant sur 312 participants reflétant une population de soins primaires. Avec plus de 4 500 instruments Roche déjà en laboratoire aux États-Unis et la certification CE Mark/IVDR récente, Roche affirme que le test peut élargir l'accès, améliorer les orientations et réduire les tests de confirmation plus invasifs tels que le PET et le CSF.
Roche (ROG) gab am 13. Oktober 2025 bekannt, dass die FDA seinen Elecsys pTau181-Bluttest als einzigen blutbasierten Biomarker-Test genehmigt hat, der in der Primärversorgung verwendet werden soll, um eine Alzheimer-assoziierte Amyloidpathologie auszuschließen. Der Test ist für Patienten ab 55 Jahren vorgesehen, wurde mit Eli Lilly entwickelt und zeigte einen negativen prädiktiven Wert von 97,9% in einer multizentrischen Studie mit 312 Teilnehmern, die eine Primärversorgungspopulation widerspiegelt. Mit über 4.500 Roche-Geräten in US-Labors und der jüngsten CE-Mark/IVDR-Zertifizierung sagt Roche, dass der Test den Zugang erweitern, Überweisungen verbessern und invasive Bestätigungstests wie PET und CSF reduzieren kann.
روش (ROG) أعلنت في 13 أكتوبر 2025 أن إدارة الغذاء والدواء الأمريكية وافقت على فحص Elecsys pTau181 بالدم كأداة بيوماركر وحيدة قائمة للاستخدام في الرعاية الأولية للمساعدة في استبعاد المرض الزهايمي المرتبط بالميلُويد. الاختبار مخصص للمرضى الذين تبلغ أعمارهم 55 عامًا فما فوق، طورته شركة إيلي ليلي، وأظهر قيمة تنبؤية سلبية تبلغ 97.9% في دراسة متعددة المراكز شملت 312 مشاركًا تعكس فئة الرعاية الأولية. مع وجود أكثر من 4,500 جهاز روشيه في المختبرات الأمريكية بالفعل وبشهادتي CE Mark/IVDR الحديثة، تقول روش إن الاختبار يمكن أن يوسع الوصول، ويحسن التحويلات، ويقلل من الاختبارات التأكيدية الأكثر تدخلاً مثل PET وCSF.
罗氏（ROG） 于 2025年10月13日 宣布，美国食品药品监督管理局已批准其 Elecsys pTau181 血液检测作为唯一的血液基 biomarker 测试，适用于 初级保健，以帮助排除与阿尔茨海默病相关的淀粉样病理。该测试适用于年龄在 55 岁及以上 的患者，由 Eli Lilly 共同开发，在一项涉及 312 名参与者、具有代表性初级保健人群的多中心研究中显示出 97.9% 的阴性预测值。美国实验室已有超过 4,500 台 Roche 仪器，且最近获得 CE 标志/IVDR 认证，罗氏表示该测试可以扩大获取渠道、改善转诊并减少更具侵入性的确认测试，如 PET 和 CSF。
- FDA clearance for primary-care use on Oct 13, 2025
- Study NPV of 97.9% in 312 participants
- CE Mark and IVDR certification in Europe
- Existing installed base of 4,500 Roche instruments in U.S. labs
- Clinical evaluation limited to 312 participants, constraining broad generalizability
- Indication limited to patients aged 55 and older, excluding younger symptomatic adults
Insights
FDA clearance enables routine primary‑care blood testing to rule out Alzheimer’s amyloid pathology, expanding access and triage.
Elecsys pTau181 now cleared by the FDA for use in primary care for patients 55 and older offers a minimally invasive biomarker that measures phosphorylated Tau‑181 in plasma. The test showed a
Adoption depends on clinician workflows, lab integration, and guideline uptake; results must be interpreted with other clinical information as stated. With > 4,500 Roche instruments installed in US labs, rapid technical deployment is feasible, but real‑world performance, clinician education, and reimbursement will determine uptake over the next 12–24 months.
Watch for real‑world validation metrics (NPV and referral changes) and payer coverage decisions within the coming year; monitor how primary‑care algorithms incorporate the test and whether specialist referral rates change meaningfully by
Clearance likely reduces need for costly confirmatory tests and improves referral efficiency, with measurable system savings.
The clearance positions the test to replace some higher‑cost procedures such as PET and CSF in the diagnostic pathway by helping rule out Alzheimer's pathology earlier. The press release highlights potential efficiency gains and preserved specialist resources, and cites the potential to reduce invasive and costly confirmatory testing.
Realized economic impact hinges on test pricing, reimbursement, and how often it changes downstream testing and specialist referrals; the clinical study size (312) and population description limit direct budget‑impact extrapolation. Expect pilots and budget analyses by health systems in the next
Key items to track: payer coverage decisions, per‑test price and coding, real‑world reduction in PET/CSF utilization, and any changes in neurologist referral volumes and wait times by
- Rules out Alzheimer's pathology in early stages to enhance diagnostic pathway efficiency
- Provides new opportunity to broaden access and improve referral quality
- Features as part of Roche's growing portfolio designed to further shape Alzheimer's diagnostic pathways
Developed in collaboration with Eli Lilly and Company, this minimally invasive test provides clinicians with information that can help identify patients in early stages of cognitive decline who are unlikely to have Alzheimer's-related amyloid pathology. The result should be interpreted in conjunction with other clinical information.
"By bringing Alzheimer's blood-based biomarker testing into primary care, we can help patients and their clinicians get answers sooner to support them earlier in their journeys," said Brad Moore, President and CEO of Roche Diagnostics North America. "This milestone reflects Roche's leadership in diagnostics and our commitment to expanding access to innovative testing for patients and their clinicians."
Alzheimer's is complex, with multiple pathologies impacting more than 7 million Americans.1 Unfortunately,
Until now, Alzheimer's biomarker testing has largely been limited to specialty settings, such as neurology. By enabling use in primary care, the Elecsys pTau181 test has the potential to significantly broaden patient access to minimally invasive testing and helps preserve specialist resources. Primary care clinicians can better guide appropriate referrals so neurologists can focus on the patients most likely to need advanced evaluation and treatment.
With more than 4,500 Roche instruments already installed in clinical laboratories across
Elecsys pTau181 is the only FDA-cleared, blood-based Alzheimer's test indicated as an aid in the initial assessment for Alzheimer's and other causes of cognitive decline in the primary-care setting. The performance was evaluated in a multicenter, non-interventional clinical study in 312 participants. Results demonstrated that in an early disease-stage, low-prevalence population reflective of primary-care setting, Elecsys pTau181 could rule out Alzheimer's pathology with a
With FDA clearance, the Elecsys pTau181 test may provide information that can help healthcare providers and systems:
- Enable early-disease-stage assessment of patients with cognitive complaints by providing information that may help aiding clinicians in ruling out Alzheimer's-related amyloid pathology
- Better integrate primary care into the Alzheimer's diagnosis pathway and expand testing availability
- Improve referral quality by guiding physicians' decisions on patient referrals
- Help preserve neurologists' resources for patients with the greatest need
- Potentially reduce the use of more invasive and costly procedures such as positron emission tomography (PET) and cerebrospinal fluid (CSF) testing, thus improving efficiency and cost-effectiveness across the healthcare system
The clearance of Elecsys pTau181 is an important milestone in Roche's ongoing work to transform Alzheimer's diagnostics. Looking ahead, Roche is advancing a comprehensive portfolio that has the potential to further shape diagnostic pathways and support earlier, more accurate detection of neurological diseases. This work reflects Roche's commitment to lead with science in developing transformational solutions that both improve patient outcomes and simplify laboratory operations.
In addition to FDA clearance in
About Roche in Alzheimer's
With more than two decades of leadership in Alzheimer's research and diagnostics, Roche offers one of the broadest portfolios of diagnostic assays — from CSF and blood-based tests to digital solutions — aimed at more effectively detecting, diagnosing and monitoring the disease. The company also provides a wide range of research-use-only (RUO) assays that advance scientific understanding and support future innovation. These efforts complement Roche's pipeline of investigational medicines targeting different pathways, types and stages of Alzheimer's disease.
Roche believes that making a meaningful impact requires both scientific innovation and collaboration across healthcare, policy and the broader Alzheimer's community.
About Roche
Founded in 1896 in
For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.
Genentech, in
For more information, please visit www.roche.com.
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For Further Information
Roche Diagnostics
us.mediarelations@roche.com
Jen Dial
1-463-867-0232
jen.dial@roche.com
Amy Lynn
1-317-750-7811
amy.lynn@roche.com
References
- Biomed Central (BMC). Alzheimer's Research & Therapy:Expected and diagnosed rates of mild cognitive impairment and dementia in the
U.S. Medicare population: observational analysis. Accessed October 2025.
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FAQ
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