Quest Diagnostics to Offer FDA-Cleared Fujirebio Blood Test for Alzheimer's Disease
Quest Diagnostics (NYSE: DGX) announced plans to offer the first FDA-cleared blood-based test for Alzheimer's disease, the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio test from Fujirebio. The test will be available for clinical and research use starting summer 2025.
The FDA-cleared test demonstrated impressive clinical results with a 92% positive predictive value and 97% negative predictive value in a study of 499 patients. It's designed for adults aged 50+ showing signs of cognitive decline in specialized care settings. Quest will provide the test through its network of approximately 8,000 patient access points, including 2,000 patient service centers across the U.S.
This addition complements Quest's existing AD-Detect� portfolio of blood tests for Alzheimer's assessment, offering a less invasive and more convenient alternative to traditional amyloid PET imaging and spinal fluid testing methods.
Quest Diagnostics (NYSE: DGX) ha annunciato l'intenzione di offrire il primo test ematico per l'Alzheimer approvato dalla FDA, il test Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio di Fujirebio. Il test sarà disponibile per uso clinico e di ricerca a partire dall'estate 2025.
Il test approvato dalla FDA ha mostrato risultati clinici notevoli, con un valore predittivo positivo del 92% e un valore predittivo negativo del 97% in uno studio su 499 pazienti. È destinato ad adulti di età superiore ai 50 anni che mostrano segni di declino cognitivo in contesti di assistenza specializzata. Quest fornirà il test tramite la sua rete di circa 8.000 punti di accesso per i pazienti, inclusi 2.000 centri di assistenza pazienti negli Stati Uniti.
Questa novità integra il portafoglio AD-Detect� di Quest, che comprende test ematici per la valutazione dell'Alzheimer, offrendo un'alternativa meno invasiva e più comoda rispetto ai tradizionali metodi di imaging PET per l'amiloide e ai test su liquido cerebrospinale.
Quest Diagnostics (NYSE: DGX) anunció planes para ofrecer la primera prueba sanguÃnea para la enfermedad de Alzheimer aprobada por la FDA, el test Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio de Fujirebio. La prueba estará disponible para uso clÃnico e investigativo a partir del verano de 2025.
La prueba aprobada por la FDA mostró resultados clÃnicos impresionantes, con un valor predictivo positivo del 92% y un valor predictivo negativo del 97% en un estudio con 499 pacientes. Está diseñada para adultos mayores de 50 años que presentan signos de deterioro cognitivo en entornos de atención especializada. Quest ofrecerá la prueba a través de su red de aproximadamente 8,000 puntos de acceso para pacientes, incluyendo 2,000 centros de servicio al paciente en todo Estados Unidos.
Esta incorporación complementa el portafolio AD-Detectâ„� de Quest, que incluye pruebas sanguÃneas para la evaluación del Alzheimer, proporcionando una alternativa menos invasiva y más conveniente en comparación con los métodos tradicionales de imagen por PET amiloide y pruebas de lÃquido cefalorraquÃdeo.
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FDA ìŠ¹ì¸ ê²€ì‚¬ëŠ” 499ëª…ì˜ í™˜ìžë¥� 대ìƒìœ¼ë¡� í•� 연구ì—서 양성 예측 ê°� 92%ì™¶Ä ìŒì„± 예측 ê°� 97%ì� ë›°ì–´ë‚� ìž„ìƒ ê²°ê³¼ë¥� 보여주었습니ë‹�. ì� 검사는 ì¸ì§€ ì €í•� 징후ë¥� ë³´ì´ëŠ� 50ì„� ì´ìƒ 성ì¸ì� 위한 ì „ë¬¸ ì˜ë£Œ 환경ì—서 사용하ë„ë¡� 설계ë˜ì—ˆìŠµë‹ˆë‹�. 퀘스트는 ë¯¸êµ ì „ì—ì� 2,000ê°� í™˜ìž ì„œë¹„ìŠ� 센터ë¥� í¬í•¨í•� ì•� 8,000ê°œì˜ í™˜ìž ì ‘ê·¼ ì§€ì � 네트워í¬ë¥� 통해 검사를 ì œê³µí•� ì˜ˆì •ìž…ë‹ˆë‹�.
ì´ë²ˆ 추가ëŠ� í€˜ìŠ¤íŠ¸ì˜ ê¸°ì¡´ AD-Detectâ„� 혈액 ê²€ì‚� í¬íЏí´ë¦¬ì˜¤ë¥¼ 보완하며, ì „í†µì ì¸ ì•„ë°€ë¡œì´ë“� PET ì˜ìƒ ë°� 척수ì•� ê²€ì‚� 방법ì—� 비해 ë� 침습ì ì´ê³� ë� 편리í•� ëŒ€ì•ˆì„ ì œê³µí•©ë‹ˆë‹�.
Quest Diagnostics (NYSE : DGX) a annoncé son intention de proposer le premier test sanguin pour la maladie d'Alzheimer approuvé par la FDA, le test Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio de Fujirebio. Ce test sera disponible pour un usage clinique et de recherche à partir de l'été 2025.
Le test approuvé par la FDA a démontré des résultats cliniques impressionnants avec une valeur prédictive positive de 92% et une valeur prédictive négative de 97% lors d'une étude menée sur 499 patients. Il est destiné aux adultes de plus de 50 ans présentant des signes de déclin cognitif dans des établissements de soins spécialisés. Quest fournira le test via son réseau d'environ 8 000 points d'accès pour les patients, dont 2 000 centres de services aux patients à travers les États-Unis.
Cette nouveauté vient compléter le portefeuille AD-Detect� existant de Quest, qui comprend des tests sanguins pour l'évaluation de la maladie d'Alzheimer, offrant une alternative moins invasive et plus pratique aux méthodes traditionnelles d'imagerie PET amyloïde et d'analyse du liquide céphalorachidien.
Quest Diagnostics (NYSE: DGX) kündigte Pläne an, den ersten von der FDA zugelassenen Bluttest für Alzheimer anzubieten, den Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio Test von Fujirebio. Der Test wird ab Sommer 2025 für klinische und Forschungszwecke verfügbar sein.
Der von der FDA zugelassene Test zeigte beeindruckende klinische Ergebnisse mit einem positiven prädiktiven Wert von 92% und einem negativen prädiktiven Wert von 97% in einer Studie mit 499 Patienten. Er ist für Erwachsene ab 50 Jahren konzipiert, die Anzeichen von kognitivem Abbau in spezialisierten Pflegeeinrichtungen zeigen. Quest wird den Test über sein Netzwerk von etwa 8.000 Patientenzugangsstellen bereitstellen, darunter 2.000 Patientenservicezentren in den USA.
Diese Ergänzung ergänzt das bestehende AD-Detect�-Portfolio von Quest für Bluttests zur Alzheimer-Bewertung und bietet eine weniger invasive und bequemere Alternative zu herkömmlichen Amyloid-PET-Bildgebungsverfahren und Liquoruntersuchungen.
- First FDA-cleared blood-based test for Alzheimer's disease detection
- High accuracy with 92% positive predictive value and 97% negative predictive value
- Extensive accessibility through 8,000 patient access points nationwide
- Less invasive and more cost-effective than traditional testing methods
- Addresses a growing market with 7 million Americans having Alzheimer's
- 20% of patients show uncertain results requiring additional testing
- Limited to specialized care settings only
- Test restricted to patients aged 50 years and older
Insights
Quest's FDA-cleared Alzheimer's blood test broadens their diagnostics portfolio, potentially increasing revenue as demand grows for less invasive testing options.
Quest Diagnostics is strategically expanding its Alzheimer's disease testing capabilities by adding the first FDA-cleared blood-based test for identifying amyloid pathology associated with Alzheimer's disease to its portfolio. This move builds upon Quest's existing AD-Detect� suite of laboratory-developed tests with a more authoritative FDA-cleared option.
The Fujirebio Lumipulse test demonstrates impressive clinical accuracy with a 92% positive predictive value and 97% negative predictive value in identifying amyloid pathology. These metrics indicate high reliability in both confirming and ruling out Alzheimer's pathology, though approximately 20% of cases remain uncertain and require additional testing.
Quest's extensive infrastructure provides a significant competitive advantage for test deployment. With approximately 8,000 patient access points including 2,000 service centers across the U.S., they can rapidly scale accessibility to this less invasive diagnostic option. Traditional amyloid detection methods like PET imaging and cerebrospinal fluid analysis are more expensive, invasive, and specialist-dependent.
The market opportunity is substantial given that nearly 7 million Americans have Alzheimer's, projected to reach 14 million by 2060. Additionally, 12-18% of adults over sixty experience mild cognitive impairment, creating a large potential testing population. As new Alzheimer's therapies emerge (with 77% of physicians believing these will transform management of the disease), accurate early diagnosis becomes increasingly crucial, further driving demand for accessible testing options.
This test complements Quest's broader brain health diagnostics strategy while addressing physician preference for blood-based testing, which 94% of doctors consider more cost-effective than invasive alternatives. By centralizing testing at their specialized California laboratory, Quest can maintain quality control while leveraging their nationwide collection infrastructure to capture market share in this growing diagnostic category.
Test to be available for clinical and research use as soon as this summer, building on Quest's pioneering blood-based AD-Detect� product line for assessing symptomatic patients
Quest plans to make the test available to physicians and biopharmaceutical collaborators later this summer. The test is the first blood-based IVD test cleared by the
Through its AD-Detect� portfolio, Quest provides a suite of advanced lab-developed blood tests regulated under CLIA for assessing patients with cognitive impairment for Alzheimer's disease. The Fujirebio test offering extends this portfolio to include an FDA-cleared option for use in specialized care settings.
"Our goal is to advance access to quality and innovative blood-based tests for Alzheimer's disease. Adding the Fujirebio test to our existing blood-based tests provides the many physicians we serve with another powerful option for assessing patients for Alzheimer's disease," said Kathleen Valentine, Vice President and General Manager, Neurology, Quest Diagnostics. "Blood-based testing can be less invasive and more convenient than traditional test methods. We are excited to leverage our expansive network of patient service centers to broaden access to the Fujirebio innovation to help more at-risk individuals gain access to the insights they need sooner."
In a clinical study population of 499 patients, which closely mirrors US demographics, and when applying a dual cut point, the FDA-cleared test demonstrated a positive predictive value (PPV) of
Quest will showcase its complete line up of Alzheimer's and other neurological test innovations at this year's Alzheimer's Association International Conference (AAIC) in
"As brain health and Alzheimer's disease interventions continue to evolve, diagnosing patients earlier, when interventions can be most effective, is critical," said Michael Racke, MD, a board-certified neurologist and Medical Director of Neurology, Quest Diagnostics. "We are constantly looking for ways to help physicians and patients make the most informed decisions, and this new addition to our test menu will aid that goal."
While amyloid PET imaging and cerebral spinal fluid testing are established methods for aiding the diagnosis of Alzheimer's disease, they are significantly more expensive, invasive and specialist-dependent than blood-based tests. With a physician's order, patients can conveniently provide a blood draw for testing for the Fujirebio test and any of the AD-Detect� tests through Quest's network of patient sites. Quest maintains approximately 8,000 patient access points, including an extensive patient service center network of approximately 2,000 locations in the
Nearly Ìýhave Alzheimer's, the most prevalent dementia, a number projected to reach 14 million by 2060. Approximately 12
Quest is committed to developing and offering innovative advanced diagnostics to aid in evaluating Alzheimer's disease and other brain diseases. For more information, visit .
About Quest Diagnostics
Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of de-identifiable clinical lab results, Quest's diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in
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