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庐 G pTau 217/尾-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鈩� 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庐 G pTau 217/尾-Amyloid 1-42 Plasma Ratio di Fujirebio. Il test sar脿 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. 脠 destinato ad adulti di et脿 superiore ai 50 anni che mostrano segni di declino cognitivo in contesti di assistenza specializzata. Quest fornir脿 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 novit脿 integra il portafoglio AD-Detect鈩� di Quest, che comprende test ematici per la valutazione dell'Alzheimer, offrendo un'alternativa meno invasiva e pi霉 comoda rispetto ai tradizionali metodi di imaging PET per l'amiloide e ai test su liquido cerebrospinale.
Quest Diagnostics (NYSE: DGX) anunci贸 planes para ofrecer la primera prueba sangu铆nea para la enfermedad de Alzheimer aprobada por la FDA, el test Lumipulse庐 G pTau 217/尾-Amyloid 1-42 Plasma Ratio de Fujirebio. La prueba estar谩 disponible para uso cl铆nico e investigativo a partir del verano de 2025.
La prueba aprobada por la FDA mostr贸 resultados cl铆nicos impresionantes, con un valor predictivo positivo del 92% y un valor predictivo negativo del 97% en un estudio con 499 pacientes. Est谩 dise帽ada para adultos mayores de 50 a帽os que presentan signos de deterioro cognitivo en entornos de atenci贸n especializada. Quest ofrecer谩 la prueba a trav茅s 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 incorporaci贸n complementa el portafolio AD-Detect鈩� de Quest, que incluye pruebas sangu铆neas para la evaluaci贸n del Alzheimer, proporcionando una alternativa menos invasiva y m谩s conveniente en comparaci贸n con los m茅todos tradicionales de imagen por PET amiloide y pruebas de l铆quido cefalorraqu铆deo.
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Quest Diagnostics (NYSE : DGX) a annonc茅 son intention de proposer le premier test sanguin pour la maladie d'Alzheimer approuv茅 par la FDA, le test Lumipulse庐 G pTau 217/尾-Amyloid 1-42 Plasma Ratio de Fujirebio. Ce test sera disponible pour un usage clinique et de recherche 脿 partir de l'茅t茅 2025.
Le test approuv茅 par la FDA a d茅montr茅 des r茅sultats cliniques impressionnants avec une valeur pr茅dictive positive de 92% et une valeur pr茅dictive n茅gative de 97% lors d'une 茅tude men茅e sur 499 patients. Il est destin茅 aux adultes de plus de 50 ans pr茅sentant des signes de d茅clin cognitif dans des 茅tablissements de soins sp茅cialis茅s. Quest fournira le test via son r茅seau d'environ 8 000 points d'acc猫s pour les patients, dont 2 000 centres de services aux patients 脿 travers les 脡tats-Unis.
Cette nouveaut茅 vient compl茅ter le portefeuille AD-Detect鈩� existant de Quest, qui comprend des tests sanguins pour l'茅valuation de la maladie d'Alzheimer, offrant une alternative moins invasive et plus pratique aux m茅thodes traditionnelles d'imagerie PET amylo茂de et d'analyse du liquide c茅phalorachidien.
Quest Diagnostics (NYSE: DGX) k眉ndigte Pl盲ne an, den ersten von der FDA zugelassenen Bluttest f眉r Alzheimer anzubieten, den Lumipulse庐 G pTau 217/尾-Amyloid 1-42 Plasma Ratio Test von Fujirebio. Der Test wird ab Sommer 2025 f眉r klinische und Forschungszwecke verf眉gbar sein.
Der von der FDA zugelassene Test zeigte beeindruckende klinische Ergebnisse mit einem positiven pr盲diktiven Wert von 92% und einem negativen pr盲diktiven Wert von 97% in einer Studie mit 499 Patienten. Er ist f眉r Erwachsene ab 50 Jahren konzipiert, die Anzeichen von kognitivem Abbau in spezialisierten Pflegeeinrichtungen zeigen. Quest wird den Test 眉ber sein Netzwerk von etwa 8.000 Patientenzugangsstellen bereitstellen, darunter 2.000 Patientenservicezentren in den USA.
Diese Erg盲nzung erg盲nzt das bestehende AD-Detect鈩�-Portfolio von Quest f眉r Bluttests zur Alzheimer-Bewertung und bietet eine weniger invasive und bequemere Alternative zu herk枚mmlichen 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鈩� 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鈩� 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鈩� 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鈩� 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 听have 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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