Labcorp Launches First-of-its-Kind Immunoassay to Accelerate Path to Diagnosis of Alzheimer's Disease
Labcorp (NYSE: LH) has launched a groundbreaking blood-based biomarker test nationwide to aid in Alzheimer's disease diagnosis. The pTau-217/Beta Amyloid 42 Ratio test offers results comparable to PET imaging and CSF testing, with 95% sensitivity and specificity.
This innovative immunoassay measures two distinct biomarkers: pTau-217 and Beta Amyloid 42 in ratio, meeting performance criteria to confirm amyloid pathology consistent with Alzheimer's. The test is available at physician offices and Labcorp's 2,000+ Patient Service Centers nationwide, offering a less invasive alternative to current diagnostic methods.
With 6.9 million Americans living with Alzheimer's and diagnosis typically taking 2.8 years from symptom onset, this breakthrough aims to accelerate the diagnostic process. The test is available for both clinical trials and patient care, with data presentation scheduled at the American Association of Neurology's 2025 Annual Meeting in San Diego.
Labcorp (NYSE: LH) ha lanciato un innovativo test di biomarcatori basato sul sangue a livello nazionale per supportare la diagnosi di malattia di Alzheimer. Il test del rapporto pTau-217/Beta Amiloide 42 offre risultati comparabili all'imaging PET e ai test del liquido cerebrospinale, con una sensibilità e specificità del 95%.
Questo innovativo immunoassay misura due biomarcatori distinti: pTau-217 e Beta Amiloide 42 in rapporto, soddisfacendo i criteri di prestazione per confermare la patologia amiloide coerente con l'Alzheimer. Il test è disponibile negli studi medici e nei oltre 2.000 Centri di Servizio per i Pazienti di Labcorp a livello nazionale, offrendo un'alternativa meno invasiva ai metodi diagnostici attuali.
Con 6,9 milioni di americani che vivono con l'Alzheimer e una diagnosi che richiede tipicamente 2,8 anni dall'insorgenza dei sintomi, questa innovazione mira ad accelerare il processo diagnostico. Il test è disponibile sia per studi clinici che per la cura dei pazienti, con la presentazione dei dati programmata per il Meeting Annuale 2025 dell'American Association of Neurology a San Diego.
Labcorp (NYSE: LH) ha lanzado una innovadora prueba de biomarcadores basada en sangre a nivel nacional para ayudar en el diagnóstico de la enfermedad de Alzheimer. La prueba del cociente pTau-217/Beta Amiloide 42 ofrece resultados comparables a la imagenología PET y a las pruebas de líquido cefalorraquídeo, con una sensibilidad y especificidad del 95%.
Este innovador inmunoensayo mide dos biomarcadores distintos: pTau-217 y Beta Amiloide 42 en proporción, cumpliendo con los criterios de rendimiento para confirmar la patología amiloide consistente con el Alzheimer. La prueba está disponible en consultorios médicos y en más de 2,000 Centros de Servicio al Paciente de Labcorp a nivel nacional, ofreciendo una alternativa menos invasiva a los métodos de diagnóstico actuales.
Con 6.9 millones de estadounidenses viviendo con Alzheimer y un diagnóstico que típicamente toma 2.8 años desde el inicio de los síntomas, este avance tiene como objetivo acelerar el proceso de diagnóstico. La prueba está disponible tanto para ensayos clínicos como para el cuidado del paciente, con la presentación de datos programada para la Reunión Anual 2025 de la Asociación Americana de Neurología en San Diego.
랩코프 (NYSE: LH)는 알츠하이머병 진단을 돕기 위해 전국적으로 혁신적인 혈액 기반 바이오마커 테스트를 출시했습니다. pTau-217/베타 아밀로이드 42 비율 테스트는 PET 이미징 및 CSF 테스트와 비교할 수 있는 결과를 제공하며, 민감도와 특이도는 95%입니다.
이 혁신적인 면역분석법은 두 가지 별개의 바이오마커인 pTau-217과 베타 아밀로이드 42의 비율을 측정하여 알츠하이머와 일치하는 아밀로이드 병리를 확인하기 위한 성능 기준을 충족합니다. 이 테스트는 의사 사무실과 전국의 2,000개 이상의 랩코프 환자 서비스 센터에서 제공되며, 현재의 진단 방법에 비해 덜 침습적인 대안을 제공합니다.
6.9백만 명의 미국인이 알츠하이머를 앓고 있으며, 진단은 일반적으로 증상 발현 후 2.8년이 걸리기 때문에, 이 혁신은 진단 과정을 가속화하는 것을 목표로 합니다. 이 테스트는 임상 시험과 환자 치료 모두에 사용할 수 있으며, 데이터 발표는 2025년 샌디에고에서 열리는 미국 신경학회 연례 회의에서 예정되어 있습니다.
Labcorp (NYSE: LH) a lancé un test de biomarqueurs révolutionnaire basé sur le sang à l'échelle nationale pour aider au diagnostic de la maladie d'Alzheimer. Le test du rapport pTau-217/Bêta Amyloïde 42 offre des résultats comparables à l'imagerie par PET et aux tests du LCR, avec une sensibilité et une spécificité de 95%.
Ce nouvel immunoessai mesure deux biomarqueurs distincts : pTau-217 et Bêta Amyloïde 42 en ratio, répondant aux critères de performance pour confirmer la pathologie amyloïde cohérente avec l'Alzheimer. Le test est disponible dans les cabinets médicaux et dans plus de 2 000 Centres de Services aux Patients de Labcorp à travers le pays, offrant une alternative moins invasive aux méthodes de diagnostic actuelles.
Avec 6,9 millions d'Américains vivant avec l'Alzheimer et un diagnostic qui prend généralement 2,8 ans après l'apparition des symptômes, cette avancée vise à accélérer le processus de diagnostic. Le test est disponible à la fois pour les essais cliniques et les soins aux patients, avec une présentation des données prévue lors de la Réunion Annuelle 2025 de l'American Association of Neurology à San Diego.
Labcorp (NYSE: LH) hat einen bahnbrechenden blutbasierten Biomarker-Test landesweit eingeführt, um die Diagnose von Alzheimer zu unterstützen. Der pTau-217/Beta-Amyloid-42-Verhältnis-Test bietet Ergebnisse, die mit PET-Bildgebung und Liquoruntersuchungen vergleichbar sind, mit einer Sensitivität und Spezifität von 95%.
Dieser innovative Immunoassay misst zwei verschiedene Biomarker: pTau-217 und Beta-Amyloid 42 im Verhältnis und erfüllt die Leistungsanforderungen zur Bestätigung der mit Alzheimer übereinstimmenden Amyloidpathologie. Der Test ist in Arztpraxen und in über 2.000 Patientendienstzentren von Labcorp im ganzen Land verfügbar und bietet eine weniger invasive Alternative zu den derzeitigen Diagnosemethoden.
Mit 6,9 Millionen Amerikanern, die mit Alzheimer leben, und einer Diagnose, die typischerweise 2,8 Jahre nach dem Auftreten der Symptome erfolgt, zielt dieser Durchbruch darauf ab, den Diagnoseprozess zu beschleunigen. Der Test ist sowohl für klinische Studien als auch für die Patientenversorgung verfügbar, und die Datenpräsentation ist für das Jahresmeeting 2025 der American Association of Neurology in San Diego geplant.
- First-of-its-kind blood test with 95% accuracy for Alzheimer's diagnosis
- Nationwide availability through 2,000+ Patient Service Centers
- Less invasive and potentially more cost-effective than current diagnostic methods
- Dual application for clinical trials and patient care
- None.
Insights
Labcorp's launch of the pTau-217/Beta Amyloid 42 Ratio blood test represents a significant diagnostic breakthrough for Alzheimer's disease. The test's reported
This advancement addresses a critical gap in Alzheimer's care. The current 2.8-year average delay between symptom onset and diagnosis significantly impacts treatment outcomes, as intervention effectiveness typically correlates with earlier initiation. By replacing invasive lumbar punctures and expensive PET imaging with a simple blood draw, Labcorp is democratizing access to advanced diagnostics.
The dual biomarker approach measuring both pTau-217 and Beta Amyloid 42 is particularly noteworthy. These markers are scientifically validated indicators of Alzheimer's pathology. Their detection in blood at levels correlating with brain pathology represents remarkable technical achievement in assay sensitivity.
The nationwide availability through Labcorp's 2,000+ Patient Service Centers eliminates geographic barriers to testing. Furthermore, its dual applicability to both clinical care and research trials may accelerate therapeutic development by improving patient selection and stratification for clinical studies.
This test could fundamentally reshape the Alzheimer's diagnostic pathway, potentially becoming the initial screening tool before proceeding to more intensive diagnostics, thereby streamlining the evaluation process and reducing healthcare system burden.
Labcorp's introduction of this novel Alzheimer's diagnostic test represents a substantial market opportunity given the 6.9 million Americans currently living with Alzheimer's disease—a figure projected to nearly double by 2050. This positions the company to capture significant market share in the expanding neurological diagnostics segment.
The test's comparable performance to PET imaging and CSF testing creates a compelling value proposition. Current diagnostic pathways involving PET scans typically cost
The nationwide rollout leveraging Labcorp's existing 2,000+ Patient Service Centers enables immediate scale without significant additional infrastructure investment. This efficient deployment strategy maximizes potential return on R&D investment.
Particularly noteworthy is the test's dual application for both clinical care and research trials. This positions Labcorp to secure pharmaceutical partnerships as companies developing Alzheimer's therapeutics require reliable biomarker testing for patient selection and treatment monitoring.
The timing is strategic, coinciding with increased FDA approval activity for Alzheimer's treatments targeting amyloid pathology. As these therapies require confirmation of amyloid presence for appropriate patient selection, Labcorp's test addresses a critical companion diagnostic need that could drive sustained demand.
This innovation strengthens Labcorp's specialized diagnostics portfolio, potentially generating both direct test revenue and downstream testing opportunities as patients enter treatment pathways.
Labcorp's pTau-217/Beta Amyloid 42 Ratio blood test meets the performance criteria to confirm amyloid pathology consistent with Alzheimer's disease
The pTau-217/Beta Amyloid 42 Ratio supports neurologists, dementia specialists and their patients by offering results that are comparable to positron emission tomography (PET) imaging and cerebrospinal fluid (CSF) testing obtained through lumbar puncture. Labcorp's test meets performance criteria to confirm the presence of amyloid pathology consistent with Alzheimer's disease, and, in connection with clinical findings, supports an accelerated path to diagnosis in patients being evaluated for Alzheimer's disease and other causes of cognitive decline.
An estimated 6.9 million Americans are living with Alzheimer's disease, a number expected to nearly double by 2050. The average time between onset of symptoms and diagnosis of Alzheimer's disease is approximately 2.8 years. Today, an Alzheimer's diagnosis often involves amyloid PET imaging and invasive CSF testing, which can be costly, time-consuming and uncomfortable.
"For too many patients and their families, the journey from symptoms to diagnosis of Alzheimer's disease can be long, difficult and uncertain," said Dr. Brian Caveney, Labcorp's chief medical and scientific officer. "Our pTau-217/Beta Amyloid 42 Ratio is a significant breakthrough, improving the diagnostic process for a complex disease. This test has the potential to reduce the time and anxiety associated with identifying Alzheimer's disease, enabling patients and their families to make more timely and informed treatment decisions."
Key Features of Labcorp's pTau-217/Beta Amyloid 42 Ratioi
- A first-of-its-kind immunoassay measuring two distinct biomarkers known as indicators of Alzheimer's disease: pTau-217 and Beta Amyloid 42, in ratio.
- Offers a sensitivity and specificity of
95% , which is substantially equivalent to the performance of amyloid PET imaging and CSF testing. - Patient blood draws can be completed in a physician's office or any of Labcorp's more than 2,000 Patient Service Centers (PSCs) nationwide.
- Available for use in clinical trials in addition to clinical patient care.
Labcorp will present data related to the pTau-217/Beta Amyloid 42 Ratio at the American Association of Neurology's 2025 Annual Meeting April 5 – 9 in
For more information, visit Labcorp's Alzheimer's disease testing portfolio.
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
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i This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration. This test is not intended as a screening test for Alzheimer's disease in asymptomatic individuals. |
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SOURCE Labcorp
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