Labcorp Launches First FDA-Cleared Blood Test for Alzheimer's Disease
Labcorp (NYSE:LH) has launched the Lumipulse庐 pTau-217/Beta Amyloid 42 Ratio, the first FDA-cleared blood test for Alzheimer's disease diagnosis. This groundbreaking test demonstrates 92% positive predictive value and 97% negative predictive value in clinical studies.
The blood-based diagnostic test provides comparable results to traditional methods like CSF testing and PET scans, but through a simpler, more affordable, and less invasive blood draw. Available nationwide through Labcorp's 2,200+ Patient Service Centers, the test is designed for adults 50 and older showing cognitive decline symptoms in specialized care settings.
Labcorp (NYSE:LH) ha lanciato il Lumipulse庐 pTau-217/Beta Amyloid 42 Ratio, il primo test del sangue approvato dalla FDA per la diagnosi della malattia di Alzheimer. Questo test innovativo ha dimostrato un 92% di valore predittivo positivo e un 97% di valore predittivo negativo negli studi clinici.
Il test ematico fornisce risultati comparabili ai metodi tradizionali come l'analisi del liquor (CSF) e la PET, ma con un prelievo di sangue pi霉 semplice, meno invasivo e pi霉 economico. Disponibile a livello nazionale presso i 2.200+ Patient Service Centers di Labcorp, il test 猫 pensato per adulti di et脿 pari o superiore a 50 anni che manifestano sintomi di declino cognitivo in contesti di cura specialistica.
Labcorp (NYSE:LH) ha lanzado el Lumipulse庐 pTau-217/Beta Amyloid 42 Ratio, la primera prueba de sangre aprobada por la FDA para el diagn贸stico de la enfermedad de Alzheimer. Esta prueba pionera mostr贸 un 92% de valor predictivo positivo y un 97% de valor predictivo negativo en estudios cl铆nicos.
La prueba basada en sangre ofrece resultados comparables a m茅todos tradicionales como el an谩lisis de LCR (CSF) y las exploraciones PET, pero mediante una extracci贸n de sangre m谩s sencilla, menos invasiva y m谩s econ贸mica. Est谩 disponible en todo el pa铆s a trav茅s de los 2.200+ Patient Service Centers de Labcorp y est谩 destinada a adultos de 50 a帽os o m谩s que presenten s铆ntomas de deterioro cognitivo en entornos de atenci贸n especializada.
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鞚� 順堨暋 旮半皹 歆勲嫧瓴�靷姅 雵岇矙靾橃暋 瓴�靷�(CSF)雮� PET 鞀れ簲 霌� 旮办〈 氚╇矔瓿� 鞙犾偓頃� 瓴瓣臣毳� 鞝滉车頃橂┐靹滊弰, 氤措嫟 臧勲嫧頃橁碃 牍勳毄 須湪鞝侅澊氅� 雿� 旃姷鞝侅澑 順堨暋 毂勳法搿� 鞁滍枆頃� 靾� 鞛堨姷雼堧嫟. Labcorp鞚� 2,200臧� 鞚挫儊鞚� Patient Service Centers鞐愳劀 鞝勱淡鞝侅溂搿� 鞚挫毄 臧�電ロ晿氅�, 鞝勲 歆勲 頇橁步鞐愳劀 鞚胳 鞝�頃� 歃濎儊鞚� 氤挫澊電� 50靹� 鞚挫儊 靹膘澑鞚� 雽�靸侅溂搿� 靹り硠霅橃棃鞀惦媹雼�.
Labcorp (NYSE:LH) a lanc茅 le Lumipulse庐 pTau-217/Beta Amyloid 42 Ratio, le premier test sanguin approuv茅 par la FDA pour le diagnostic de la maladie d'Alzheimer. Ce test r茅volutionnaire a montr茅 une valeur pr茅dictive positive de 92% et une valeur pr茅dictive n茅gative de 97% dans les 茅tudes cliniques.
Le test sanguin fournit des r茅sultats comparables aux m茅thodes traditionnelles telles que l'analyse du LCR (CSF) et les scans PET, mais par une prise de sang plus simple, moins invasive et moins co没teuse. Disponible 脿 l'茅chelle nationale via les 2 200+ Patient Service Centers de Labcorp, le test est destin茅 aux adultes de 50 ans et plus pr茅sentant des sympt么mes de d茅clin cognitif dans des structures de soins sp茅cialis茅es.
Labcorp (NYSE:LH) hat den Lumipulse庐 pTau-217/Beta Amyloid 42 Ratio eingef眉hrt, den ersten von der FDA zugelassenen Bluttest zur Diagnose der Alzheimer-Krankheit. Dieser bahnbrechende Test zeigte in klinischen Studien einen positiven pr盲diktiven Wert von 92% und einen negativen pr盲diktiven Wert von 97%.
Der blutbasierte Diagnosetest liefert Ergebnisse, die mit traditionellen Verfahren wie Liquoruntersuchungen (CSF) und PET-Scans vergleichbar sind, erm枚glicht jedoch eine einfachere, kosteng眉nstigere und weniger invasive Blutentnahme. Der Test ist landesweit 眉ber Labcorps 2.200+ Patient Service Centers verf眉gbar und richtet sich an Erwachsene ab 50 Jahren mit Anzeichen kognitiver Beeintr盲chtigung in spezialisierten Versorgungseinrichtungen.
- First FDA-cleared blood test for Alzheimer's disease diagnosis
- High accuracy with 92% positive and 97% negative predictive values
- More affordable and accessible alternative to traditional diagnostic methods
- Nationwide availability through 2,200+ Patient Service Centers
- Test cannot be used as a standalone diagnostic tool
- Limited to specialized care settings only
- Restricted to patients 50 years and older with existing cognitive decline symptoms
Insights
Labcorp's FDA-cleared Alzheimer's blood test represents a significant diagnostic advancement with strong market potential and competitive advantage.
Labcorp's launch of the Lumipulse庐 pTau-217/Beta Amyloid 42 Ratio test marks a pivotal advancement in Alzheimer's diagnostics. This first FDA-cleared blood-based test for detecting amyloid plaques offers compelling clinical performance with a
The test's significance lies in its transformation of the diagnostic process. Traditional Alzheimer's diagnosis requires lumbar punctures for CSF analysis or expensive PET scans, creating barriers to early detection. This blood test dramatically improves accessibility while maintaining diagnostic reliability, potentially accelerating both diagnosis and treatment initiation.
The timing is strategically important, aligning with new Alzheimer's Association clinical guidelines supporting blood-based biomarkers in specialty care settings. This regulatory and clinical endorsement strengthens market positioning and adoption potential.
Labcorp's nationwide distribution network of over 2,200 Patient Service Centers creates a substantial competitive advantage for rapid market penetration. The company has effectively replaced its earlier version launched in April 2025 with this FDA-cleared test, demonstrating progressive improvement in their diagnostic portfolio.
For patients aged 50+ showing cognitive decline symptoms, this test represents a less invasive, more affordable diagnostic tool that maintains clinical accuracy while significantly improving the patient experience.
Lumipulse庐 pTau-217/Beta Amyloid 42 Ratio now available nationwide through Labcorp
The test offers results that are comparable to existing methods that support a diagnosis of Alzheimer's disease 鈥� cerebrospinal fluid (CSF) testing obtained through lumbar puncture and positron emission tomography (PET) scans 鈥� but from a simple blood draw, making it more affordable, more accessible and less invasive. Fujirebio reports that in clinical studies, the test demonstrated a positive predictive value of
"The path to an Alzheimer's diagnosis has long meant a diagnostic journey requiring years of invasive procedures and expensive imaging," said Dr. Brian Caveney, chief medical and scientific officer at Labcorp. "Clinicians need better ways to diagnose their patients more quickly, enroll them in clinical trials, or start therapies. By offering this FDA-cleared blood test nationwide,聽Labcorp is leading the way in delivering innovative solutions for Alzheimer's disease and other neurological conditions by helping patients, families and physicians get answers sooner."聽
The launch of this test closely follows the release of a new clinical guideline from the Alzheimer's Association, which supports the use of blood-based biomarkers to help evaluate patients suspected of Alzheimer's disease in specialty care settings. The guideline highlights the growing clinical consensus around these tools and reinforces the importance of expanding access.
The Lumipulse pTau-217/Beta Amyloid 42 Ratio is intended for adults aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline. It is not intended as a screening or stand-alone diagnostic test and must be interpreted in conjunction with other clinical information of the patient. Once ordered, patients can complete the blood draw in a healthcare provider's office or any of Labcorp's more than 2,200 Patient Service Centers (PSCs) nationwide.
The FDA-cleared test builds on and replaces a similar pTau-217/Beta Amyloid 42 Ratio test that the company in April 2025.
For more information about Labcorp's portfolio of blood-based biomarkers for Alzheimer's disease and dementia, visit
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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