Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer鈥檚 disease
Roche (OTCQX: RHHBY) has achieved a significant milestone with CE Mark approval for its Elecsys pTau181 blood test, designed to rule out Alzheimer's disease. This minimally invasive test, developed in collaboration with Eli Lilly, measures phosphorylated Tau protein levels to indicate amyloid pathology.
The test demonstrated impressive clinical results with a 93.8% negative predictive value and 83.6% sensitivity in a comprehensive study of 787 patients across the US, Europe, and Australia. This breakthrough could significantly reduce the need for more invasive and expensive diagnostic procedures like PET scans and CSF assessments for patients with negative results.
Additionally, Roche is developing the Elecsys pTau217 blood test, showing promising results in detecting amyloid pathology with enhanced sample stability at various temperatures.
Roche (OTCQX: RHHBY) ha raggiunto un traguardo importante con l'approvazione CE per il suo test del sangue Elecsys pTau181, progettato per escludere la malattia di Alzheimer. Questo test minimamente invasivo, sviluppato in collaborazione con Eli Lilly, misura i livelli della proteina Tau fosforilata per indicare la presenza di patologia amiloide.
Il test ha mostrato risultati clinici notevoli con un valore predittivo negativo del 93,8% e una sensibilit脿 dell'83,6% in uno studio completo su 787 pazienti negli Stati Uniti, in Europa e in Australia. Questa innovazione potrebbe ridurre significativamente la necessit脿 di procedure diagnostiche pi霉 invasive e costose come la PET e le valutazioni del liquido cerebrospinale per i pazienti con risultati negativi.
Inoltre, Roche sta sviluppando il test del sangue Elecsys pTau217, che mostra risultati promettenti nel rilevare la patologia amiloide con una maggiore stabilit脿 del campione a diverse temperature.
Roche (OTCQX: RHHBY) ha alcanzado un hito importante con la aprobaci贸n del marcado CE para su prueba de sangre Elecsys pTau181, dise帽ada para descartar la enfermedad de Alzheimer. Esta prueba m铆nimamente invasiva, desarrollada en colaboraci贸n con Eli Lilly, mide los niveles de prote铆na Tau fosforilada para indicar la patolog铆a amiloide.
La prueba mostr贸 resultados cl铆nicos impresionantes con un valor predictivo negativo del 93,8% y una sensibilidad del 83,6% en un estudio exhaustivo con 787 pacientes en EE. UU., Europa y Australia. Este avance podr铆a reducir significativamente la necesidad de procedimientos diagn贸sticos m谩s invasivos y costosos, como las exploraciones PET y las evaluaciones del l铆quido cefalorraqu铆deo, para pacientes con resultados negativos.
Adem谩s, Roche est谩 desarrollando la prueba de sangre Elecsys pTau217, que presenta resultados prometedores para detectar la patolog铆a amiloide con mayor estabilidad de las muestras a diferentes temperaturas.
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鞚� 瓴�靷姅 氙戈淡, 鞙犽熃, 順胳＜鞐愳劀 787氇呾潣 頇橃瀽毳� 雽�靸侅溂搿� 頃� 韽磩鞝� 鞐瓣惮鞐愳劀 93.8%鞚� 鞚岇劚 鞓堨浮 臧�瓿� 83.6%鞚� 氙缄皭霃�霛茧姅 霙办柎雮� 鞛勳儊 瓴瓣臣毳� 氤挫棳欤检棃鞀惦媹雼�. 鞚� 須嶊赴鞝侅澑 瓴�靷姅 鞚岇劚 瓴瓣臣毳� 氚涭潃 頇橃瀽鞐� 雽�頃� PET 鞀れ簲 氚� 雵岇矙靾橃暋 瓴�靷檧 臧欖潃 雿� 旃姷鞝侅澊瓿� 牍勳毄鞚� 毵庫澊 霌滊姅 歆勲嫧 鞝堨皑鞚� 頃勳殧靹膘潉 韥矊 欷勳澕 靾� 鞛堨姷雼堧嫟.
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Roche (OTCQX : RHHBY) a franchi une 茅tape importante avec l'obtention du marquage CE pour son test sanguin Elecsys pTau181, con莽u pour exclure la maladie d'Alzheimer. Ce test peu invasif, d茅velopp茅 en collaboration avec Eli Lilly, mesure les niveaux de prot茅ine Tau phosphoryl茅e pour indiquer la pr茅sence d'une pathologie amylo茂de.
Le test a d茅montr茅 des r茅sultats cliniques impressionnants avec une valeur pr茅dictive n茅gative de 93,8 % et une sensibilit茅 de 83,6 % lors d'une 茅tude compl猫te men茅e aupr猫s de 787 patients aux 脡tats-Unis, en Europe et en Australie. Cette avanc茅e pourrait r茅duire consid茅rablement le recours 脿 des proc茅dures diagnostiques plus invasives et co没teuses, telles que les scanners PET et les analyses du liquide c茅phalo-rachidien, pour les patients avec des r茅sultats n茅gatifs.
Par ailleurs, Roche d茅veloppe le test sanguin Elecsys pTau217, qui montre des r茅sultats prometteurs pour d茅tecter la pathologie amylo茂de avec une meilleure stabilit茅 des 茅chantillons 脿 diff茅rentes temp茅ratures.
Roche (OTCQX: RHHBY) hat einen bedeutenden Meilenstein erreicht: die CE-Zulassung f眉r seinen Elecsys pTau181-Bluttest, der zur Ausschlussdiagnose der Alzheimer-Krankheit entwickelt wurde. Dieser minimal-invasive Test, der in Zusammenarbeit mit Eli Lilly entwickelt wurde, misst die Phosphorylierung des Tau-Proteins, um amyloide Pathologien anzuzeigen.
Der Test zeigte beeindruckende klinische Ergebnisse mit einem negativen pr盲diktiven Wert von 93,8% und einer Sensitivit盲t von 83,6% in einer umfassenden Studie mit 787 Patienten in den USA, Europa und Australien. Dieser Durchbruch k枚nnte den Bedarf an invasiveren und teureren Diagnoseverfahren wie PET-Scans und Liquoruntersuchungen bei Patienten mit negativen Ergebnissen deutlich reduzieren.
Dar眉ber hinaus entwickelt Roche den Elecsys pTau217-Bluttest, der vielversprechende Ergebnisse bei der Erkennung amyloider Pathologien mit verbesserter Probenstabilit盲t bei verschiedenen Temperaturen zeigt.
- High negative predictive value of 93.8% in clinical trials
- Potential to reduce need for expensive and invasive diagnostic procedures
- Test performance minimally impacted by patient characteristics (age, gender, BMI)
- Can be implemented effectively across various care settings, including primary care
- Development of additional Elecsys pTau217 test showing promising results
- Test sensitivity of 83.6% indicates some false negatives may occur
- Limited to ruling out Alzheimer's rather than providing definitive diagnosis
- Elecsys pTau181 is the first In Vitro Diagnostic Regulation (IVDR) certified test to rule out Alzheimer鈥檚 associated amyloid pathology.
- The minimally invasive, blood-based test can serve as a rule out for Alzheimer鈥檚 pathology, reducing the need for confirmatory testing with a negative result.
- Data from clinical study supports use in primary care for people with varying signs of cognitive decline.
Basel, 23 July 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received CE Mark for its Elecsys庐 pTau181 test to measure phosphorylated Tau (pTau) 181 protein which is an indicator of amyloid pathology, a hallmark of Alzheimer鈥檚 disease. The test, which has been developed in collaboration with Eli Lilly and Company, can be used by clinicians in conjunction with other clinical information to rule out Alzheimer鈥檚 disease as the cause of cognitive decline. This could avoid the need for further confirmatory investigation for patients testing negative.
鈥淭he burden of Alzheimer鈥檚 disease on society and healthcare systems is increasing as the world鈥檚 population ages,鈥� said Matt Sause, CEO of Roche Diagnostics. 鈥淲ith Elecsys pTau181, doctors can give patients and their caregivers the clarity they need when establishing the cause of cognitive decline. By enabling an earlier and less invasive diagnosis, this test has the potential to improve patient outcomes and decrease costs for healthcare systems worldwide.鈥�
Barriers to early and accurate diagnosis of Alzheimer鈥檚 disease exist across the world. Up to
Clinical study results support that the test can be implemented effectively across care settings, including primary care, where most patients first seek help for cognitive concerns. Those with positive results are then able to undergo further testing, supporting earlier identification of Alzheimer鈥檚 pathology. This is key to accessing new treatments that are most effective when used early in the disease progression, enabling patients to make informed decisions about their future care.
Clinical data support the Elecsys pTau181 test for varying signs of cognitive decline
The CE Mark for the Elecsys pTau181 blood test was based on data from a prospective, multicentre study, which included 787 patients across the US, Europe and Australia. The study showed the test was able to rule out Alzheimer鈥檚 disease with a high negative predictive value (NPV) of
This global, prospectively-collected, diagnostic registrational clinical study was the first of its kind in the industry to investigate the test鈥檚 clinical performance in a diverse patient population, aged 55-80 years old that reflects as closely as possible the patients who could benefit from the test. It involved a subset of patients from a wider study looking at a highly diverse set of patients with broad inclusion criteria, to ensure the test could be used effectively across different geographies and ethnicities.
Elecsys pTau217 blood test
Roche is also developing the Elecsys pTau217 blood test, an in-vitro diagnostic immunoassay for the quantitative determination of the protein Phospho-Tau (217P) in human plasma for use as an aid in identifying amyloid pathology. Recent data presented on Elecsys pTau217 showed that it was able to accurately detect amyloid pathology and was more stable than a pTau217/A尾42 ratio in blood and plasma samples at room and refrigerator temperatures. Together with the high throughput and full automation of the assay, these data support the potential of Elecsys pTau217 as an accurate standalone test that could be scaled up for broad implementation in routine clinical practice worldwide across Roche鈥檚 unmatched installed base.
About Roche in Alzheimer鈥檚
With more than two decades of scientific research in Alzheimer鈥檚 disease, Roche is working towards a day when we can detect and treat the disease early, in order to stop or even prevent its progression to preserve what makes people who they are. Today, the company鈥檚 Alzheimer鈥檚 disease portfolio spans investigational medicines for different targets, types and stages of the disease, including trontinemab. On the diagnostics side, it also includes approved and investigational tools, including digital, blood-based tests and CSF assays, aiming to more effectively detect, diagnose and monitor the disease. Yet the global challenges of Alzheimer鈥檚 disease go well beyond the capabilities of science, and making a meaningful impact requires collaboration both within the Alzheimer鈥檚 community and outside of healthcare. Roche will continue to work together with numerous partners with the hope to transform millions of lives.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world鈥檚 largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
For over 125 years, sustainability has been an integral part of Roche鈥檚 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 the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
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References
[1] Alzheimer鈥檚 Disease International. World Alzheimer Report 2022 [Internet; cited April 2025]. Available from: . Last accessed: April 2025
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