New Multi-Marker Blood Test from Lucent Diagnostics Increases the Number of Patients Receiving Early Alzheimer’s Disease Diagnostic Information
Lucent Diagnostics, a Quanterix (NASDAQ: QTRX) brand, has launched LucentAD Complete, an advanced multi-marker blood test for Alzheimer's Disease detection. The test utilizes a proprietary algorithm analyzing five AD-related biomarkers to improve amyloid classification compared to single-marker tests. In trials across three independent clinical cohorts involving over 1,000 patients, the test reduced the 'intermediate zone' of uncertainty by threefold, minimizing the need for invasive lumbar punctures or costly PET scans. The development was supported by the Alzheimer's Drug Discovery Foundation's Diagnostics Accelerator.
Lucent Diagnostics, un marchio di Quanterix (NASDAQ: QTRX), ha lanciato LucentAD Complete, un avanzato test ematico multi-marcatore per la rilevazione dell'Alzheimer. Il test utilizza un algoritmo proprietario che analizza cinque biomarcatori correlati all'AD per migliorare la classificazione dell'amiloide rispetto ai test a marcatore singolo. Negli studi condotti su tre coorti cliniche indipendenti che coinvolgono oltre 1.000 pazienti, il test ha ridotto di tre volte la 'zona intermedia' di incertezza, minimizzando la necessità di punture lombari invasive o costose scansioni PET. Lo sviluppo è stato supportato dall'Alzheimer's Drug Discovery Foundation's Diagnostics Accelerator.
Lucent Diagnostics, una marca de Quanterix (NASDAQ: QTRX), ha lanzado LucentAD Complete, una prueba de sangre avanzada de múltiples marcadores para la detección de la enfermedad de Alzheimer. La prueba utiliza un algoritmo propietario que analiza cinco biomarcadores relacionados con el AD para mejorar la clasificación de amiloides en comparación con pruebas de un solo marcador. En ensayos realizados en tres cohortes clínicas independientes que involucraron a más de 1,000 pacientes, la prueba redujo por tres veces la 'zona intermedia' de incertidumbre, minimizando la necesidad de punciones lumbares invasivas o costosas exploraciones por PET. El desarrollo fue apoyado por el Diagnostics Accelerator de la Alzheimer's Drug Discovery Foundation.
Lucent Diagnostics는 Quanterix (NASDAQ: QTRX)의 브랜드로서 LucentAD Complete를 출시했습니다. 이는 알츠하이머병 탐지를 위한 고급 다중 바이오마커 혈액 검사입니다. 이 검사는 5개의 AD 관련 바이오마커를 분석하는 독점 알고리즘을 사용하여 단일 바이오마커 검사와 비교하여 아밀로이드 분류를 개선합니다. 1,000명 이상의 환자를 포함한 3개의 독립적인 임상 집단에서 진행된 시험에서 이 검사는 '중간 불확실성 영역'을 3배 줄여 침습적인 요추천자를 수행하거나 비용이 많이 드는 PET 스캔의 필요성을 최소화했습니다. 이 개발은 알츠하이머 약물 발견 재단의 진단 가속기(Diagnostics Accelerator)의 지원을 받았습니다.
Lucent Diagnostics, une marque de Quanterix (NASDAQ: QTRX), a lancé LucentAD Complete, un test sanguin avancé multi-marqueur pour la détection de la maladie d'Alzheimer. Le test utilise un algorithme propriétaire analysant cinq biomarqueurs liés à l'AD pour améliorer la classification des amyloïdes par rapport aux tests à marqueur unique. Dans des essais menés sur trois cohortes cliniques indépendantes impliquant plus de 1 000 patients, le test a réduit par trois la 'zone intermédiaire' d'incertitude, minimisant ainsi la nécessité de ponctions lombaires invasives ou de scans PET coûteux. Le développement a été soutenu par le Diagnostics Accelerator de la Alzheimer's Drug Discovery Foundation.
Lucent Diagnostics, eine Marke von Quanterix (NASDAQ: QTRX), hat LucentAD Complete eingeführt, einen fortschrittlichen Bluttest mit mehreren Markern zur Erkennung der Alzheimer-Krankheit. Der Test nutzt einen proprietären Algorithmus, der fünf AD-bezogene Biomarker analysiert, um die Amyloidklassifizierung im Vergleich zu Tests mit nur einem Marker zu verbessern. In Studien mit drei unabhängigen klinischen Kohorten, die mehr als 1.000 Patienten umfassten, reduzierte der Test die 'intermediäre Zone' der Unsicherheit um das Dreifache und minimierte so die Notwendigkeit invasiver Lumbalpunktionen oder kostspieliger PET-Scans. Die Entwicklung wurde von der Alzheimer's Drug Discovery Foundation's Diagnostics Accelerator unterstützt.
- Successfully tested on over 1,000 patients across three independent clinical cohorts
- Reduces intermediate zone uncertainty by threefold compared to single-marker tests
- Meets guideline performance standards for blood-based Alzheimer's diagnostic testing
- Received development funding from Alzheimer's Drug Discovery Foundation
- None.
Insights
The launch of LucentAD Complete represents a significant advancement in Alzheimer's diagnostics. The test's ability to reduce intermediate zone results by
The proprietary algorithm analyzing five AD biomarkers (p-Tau 217, Aβ42/40, NfL, GFAP) offers superior amyloid classification compared to single-marker tests. This could potentially reduce the need for expensive PET scans and invasive lumbar punctures, leading to cost savings and improved patient experience. The ADDF's funding support and validation of the multi-biomarker approach adds significant credibility to this diagnostic advancement.
This product launch strengthens Quanterix's position in the growing Alzheimer's diagnostics market, estimated to reach
The test's CLIA validation and backing from the Alzheimer's Drug Discovery Foundation positions Quanterix favorably against competitors. The company's Simoa platform's multiplex capabilities create barriers to entry and potential for expanded applications in other neurological conditions.
LucentADTM Complete improves on single biomarker tests, significantly reducing the intermediate zone, providing results for more patients
Recent Alzheimer’s Association criteria for diagnosing Alzheimer’s recommend that plasma p-Tau 217 tests be designed with two cutoffs to confidently differentiate between patients with or without amyloid pathology, a hallmark of AD. However, this approach leaves an “intermediate zone” of uncertainty, requiring patients that fall into this zone follow up with cerebral spinal fluid measurement via invasive lumbar puncture or costly amyloid PET scans. LucentAD Complete addresses this by reducing the number of patients that fall into the intermediate zone by threefold. The test uses a proprietary algorithm to score five AD-related biomarkers (p-Tau 217, Aβ42/40, NfL, GFAP) providing significantly better amyloid classification compared to single-marker tests alone.
“In over 1,000 patients across three independent clinical cohorts, we achieved guideline performance standard for a blood-based Alzheimer’s diagnostic test, while significantly increasing conclusive results for more patients versus p-Tau 217 alone,” said Masoud Toloue, CEO of Quanterix. “This test confirms our multi-marker approach as the next phase in the evolution of blood-based testing for AD, and we are excited to present our results at the Clinical Trials on Alzheimer’s Disease (CTAD) conference.”
The test development was funded by the Alzheimer’s Drug Discovery Foundation's Diagnostics Accelerator.
“Alzheimer’s is a multifaceted disease and as such, we will need a multi biomarker approach to detect the various underlying pathologies. Multiplex platforms, like Quanterix’s Simoa platform, offer the potential to move us closer to a precision medicine approach,” said Howard Fillit, MD, Co-Founder and Chief Science Officer at Alzheimer’s Drug Discovery Foundation. “The ability of LucentAD’s test to reduce the intermediate zone of pTau testing further demonstrates that Alzheimer’s is not a single biomarker disease.”
Healthcare providers interested in learning more about Lucent Diagnostics or how to access LucentAD Complete, please visit: https://www.lucentdiagnostics.com/
For more information about Quanterix’s work in neurology, visit: https://www.quanterix.com/therapeutic-areas/neurology/.
The Lucent Diagnostics’ tests have been developed and validated by Quanterix Corporation (CLIA# 22D1053083) in a manner consistent with CLIA requirements.
About Lucent Diagnostics
Lucent Diagnostics, a commercial brand of Quanterix, was created in 2023 to deliver revolutionary tools that aid in the earlier detection of cognitive disease. Powered by the ultra-sensitive Simoa® technology, Lucent Diagnostics bridges the gap between research and clinical use by offering products and services designed specifically to meet the separate needs of institutions and healthcare providers. With more than a decade of proven success within the neurology research space, supported by thousands of publications and partnerships, Quanterix aims to directly impact the landscape of cognitive disease through its commercial brand, Lucent Diagnostics. For more information, please visit www.LucentDiagnostics.com
About Quanterix
From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. The Company’s Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Limit of Quantification (LoQ) of conventional analog methods. Its industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology and infectious disease. Quanterix has been a trusted partner of the scientific community for nearly two decades, powering research published in more than 2,900 peer-reviewed journals. Find additional information about the
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Source: Quanterix
FAQ
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