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Revvity';s EUROIMMUN Launches Solution for Specific Typing of Alzheimer's Disease Associated APOE Gene

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Revvity (NYSE: RVTY) has announced the launch of the EURORealTime APOE assay, an in-vitro diagnostic test for APOE genotyping in European countries accepting the CE mark. This test is important for assessing a patient's risk of side effects before starting anti-amyloid therapy for Alzheimer's disease.

The assay allows simultaneous detection of the three most frequent APOE forms (E2, E3, and E4), with E4 carriers having the highest risk for ARIA (Amyloid-Related Imaging Abnormalities) under therapy. The test requires only one reaction using genomic DNA from a single blood sample and can be automated on Revvity instruments, including the EUROIMMUN PreNAT II and chemagic 360 platforms.

This new solution will enable clinicians to take a more personalized approach in anti-amyloid treatment for Alzheimer's patients by providing additional patient information through APOE genotyping.

Revvity (NYSE: RVTY) ha annunciato il lancio del test EURORealTime APOE, un test diagnostico in vitro per il genotipizzazione APOE nei paesi europei che accettano il marchio CE. Questo test è importante per valutare il rischio di effetti collaterali di un paziente prima di iniziare la terapia anti-amiloide per la malattia di Alzheimer.

Il test consente la rilevazione simultanea delle tre forme di APOE più frequenti (E2, E3 ed E4), con i portatori di E4 che hanno il rischio più elevato di ARIA (Anomalie di Imaging Relate all'Amiloide) durante la terapia. Il test richiede solo una reazione utilizzando DNA genomico da un singolo campione di sangue e può essere automatizzato su strumenti Revvity, tra cui le piattaforme EUROIMMUN PreNAT II e chemagic 360.

Questa nuova soluzione permetterà ai clinici di adottare un approccio più personalizzato nel trattamento anti-amiloide per i pazienti affetti da Alzheimer fornendo informazioni aggiuntive attraverso la genotipizzazione APOE.

Revvity (NYSE: RVTY) ha anunciado el lanzamiento de la prueba EURORealTime APOE, una prueba diagnóstica in vitro para el genotipado de APOE en países europeos que aceptan la marca CE. Esta prueba es importante para evaluar el riesgo de efectos secundarios en un paciente antes de comenzar la terapia anti-amiloide para la enfermedad de Alzheimer.

El ensayo permite la detección simultánea de las tres formas más frecuentes de APOE (E2, E3 y E4), siendo los portadores de E4 los que tienen el mayor riesgo de ARIA (Anomalías de Imágenes Relacionadas con Amiloide) durante la terapia. La prueba requiere solo una reacción utilizando ADN genómico de una sola muestra de sangre y se puede automatizar en los instrumentos de Revvity, incluidas las plataformas EUROIMMUN PreNAT II y chemagic 360.

Esta nueva solución permitirá a los clínicos adoptar un enfoque más personalizado en el tratamiento anti-amiloide para los pacientes con Alzheimer, proporcionando información adicional a través del genotipado de APOE.

Revvity (NYSE: RVTY)는 CE 마크를 승인한 유럽 국가에서 EURORealTime APOE 검사의 출시를 발표했습니다. 이 검사는 APOE 유전자형 분석을 위한 인체 외 진단 테스트입니다. 이 검사는 알츠하이머병을 위한 항-아밀로이드 치료를 시작하기 전에 환자의 부작용 위험을 평가하는 데 중요합니다.

이 검사는 E2, E3 및 E4의 세 가지 가장 일반적인 APOE 형태를 동시에 감지할 수 있으며, E4 보유자는 치료 중 ARIA (아밀로이드 관련 영상 이상)의 높은 위험을 가지고 있습니다. 이 검사는 단일 혈액 샘플에서 유전체 DNA를 사용하는 단 한 번의 반응만 필요하며, EUROIMMUN PreNAT II 및 chemagic 360 플랫폼과 같은 Revvity 기기에서 자동화할 수 있습니다.

이 새로운 솔루션은 APOE 유전자형 분석을 통해 추가적인 환자 정보를 제공하여 알츠하이머 환자에 대한 항-아밀로이드 치료에서 보다 개인화된 접근 방식을 취할 수 있도록 도와줄 것입니다.

Revvity (NYSE: RVTY) a annoncé le lancement du test EURORealTime APOE, un test diagnostique in vitro pour le génotypage APOE dans les pays européens acceptant le marquage CE. Ce test est important pour évaluer le risque d'effets secondaires chez un patient avant de commencer la thérapie anti-amyloïde pour la maladie d'Alzheimer.

Ce test permet la détection simultanée des trois formes d'APOE les plus fréquentes (E2, E3 et E4), les porteurs de l'E4 présentant le risque le plus élevé de ARIA (Anomalies d'Imagerie Reliées à l'Amiloïde) sous traitement. Le test nécessite uniquement une réaction à partir de l'ADN génomique prélevé sur un seul échantillon sanguin et peut être automatisé sur les instruments de Revvity, y compris les plateformes EUROIMMUN PreNAT II et chemagic 360.

Cette nouvelle solution permettra aux cliniciens d'adopter une approche plus personnalisée dans le traitement anti-amyloïde des patients Alzheimer en fournissant des informations supplémentaires sur les patients grâce au génotypage APOE.

Revvity (NYSE: RVTY) hat die Einführung des EURORealTime APOE-Tests bekannt gegeben, einem In-vitro-Diagnosetest für die APOE-Genotypisierung in europäischen Ländern, die das CE-Zeichen akzeptieren. Dieser Test ist wichtig, um das Risiko von Nebenwirkungen bei einem Patienten vor Beginn der Anti-Amyloid-Therapie bei Alzheimer zu bewerten.

Der Test ermöglicht die gleichzeitige Erkennung der drei häufigsten APOE-Formen (E2, E3 und E4), wobei Träger von E4 das höchste Risiko für ARIA (Amyloid-assoziierte Bildgebungsanomalien) unter Therapie haben. Der Test erfordert nur eine Reaktion mit genomischer DNA aus einer einzigen Blutprobe und kann auf Revvity-Geräten, einschließlich der EUROIMMUN PreNAT II- und chemagic 360-Plattformen, automatisiert werden.

Diese neue Lösung ermöglicht es Klinikern, einen personalisierteren Ansatz bei der Anti-Amyloid-Behandlung von Alzheimer-Patienten zu verfolgen, indem sie zusätzliche Patienteninformationen durch APOE-Genotypisierung bereitstellen.

Positive
  • Launch of EURORealTime APOE assay for CE mark countries
  • Enables assessment of patient risk for side effects in Alzheimer's therapy
  • Simultaneous detection of three most frequent APOE forms
  • Requires only one reaction from a single blood sample
  • Can be automated on Revvity instruments
Negative
  • None.

Insights

The launch of the EURORealTime APOE assay by Revvity's EUROIMMUN is a significant development in Alzheimer's disease management. This in-vitro diagnostic test allows for precise genotyping of the APOE gene, which is important for assessing a patient's risk of adverse effects from new anti-amyloid therapies.

The test's ability to detect the three most frequent APOE forms (E2, E3 and E4) in a single reaction using genomic DNA from a blood sample is a notable advancement. Carriers of the E4 form have the highest risk for ARIA (Amyloid-Related Imaging Abnormalities) under therapy, which can include potentially life-threatening brain edema or microbleedings.

This development aligns with the trend towards personalized medicine in Alzheimer's treatment. By enabling clinicians to assess individual patient risk before initiating anti-amyloid therapy, it could significantly improve patient safety and treatment outcomes. The test's automation capabilities and compatibility with Revvity instruments suggest potential for widespread adoption in clinical settings.

The launch of the EURORealTime APOE assay represents a strategic move for Revvity (NYSE: RVTY) in the growing Alzheimer's disease market. With a market cap of $15.35 billion, this product launch could potentially drive revenue growth in Revvity's diagnostics segment.

The timing is particularly advantageous, coinciding with the introduction of new disease-modifying Alzheimer's drugs. As these treatments become more prevalent, the demand for companion diagnostics like the APOE test is likely to increase significantly. This positions Revvity to capture a larger share of the Alzheimer's diagnostic market.

Investors should note that while the initial launch is in CE mark countries, expansion to other markets could provide additional growth opportunities. The test's automation capabilities also suggest potential for high-volume testing, which could translate to improved profit margins. However, the impact on Revvity's overall financial performance will depend on market adoption rates and pricing strategies.

APOE genotyping allows assessment of a patient’s risk for adverse effects from new anti-amyloid therapy for Alzheimer’s

WALTHAM, Mass.--(BUSINESS WIRE)-- Revvity, Inc. (NYSE: RVTY), announced today the launch of the in-vitro diagnostic EURORealTimeTM APOE assay in European countries that accept the CE mark, which will enable accurate genotyping of the APOE gene. APOE genotyping is valuable to assess a patient’s risk for side effects prior to the start of an anti-amyloid (beta) therapy in Alzheimer’s disease.

“With the introduction of new disease-modifying drugs for treating Alzheimer’s, a new era of therapy has begun for this incurable disease. However, it has been found that patients taking these treatments with a certain form of the APOE gene have a significant risk for developing potentially life-threatening side effects, called ARIA, referring to edema or microbleedings in the brain,” explains Dr. Lars Komorowski, chief scientific officer of EUROIMMUN. “Being able to easily determine the APOE genotype of patients before starting therapy is key to assessing the individual risk for potential negative consequences.”

The real-time EURORealTime APOE PCR test allows simultaneous detection of the three most frequent APOE forms, designated E2, E3 and E4. Carriers of exclusively E4 exhibit the highest risk for ARIA under therapy. With the new test now available from Revvity’s EUROIMMUN, only one reaction is required using genomic DNA isolated from a single blood sample to determine the patient’s APOE genotype. The assay processing can be automated to scalable degrees on Revvity instruments, including the EUROIMMUN PreNAT IITM and the chemagic™ 360 platforms. Results are evaluated, documented and archived using the EURORealTime analysis software.

For clinicians treating Alzheimer’s patients, this approach to APOE genotyping will grant additional patient information and will enable a more personalized approach in anti-amyloid (beta) treatment.

About Revvity

At Revvity, “impossible” is inspiration, and “can’t be done” is a call to action. Revvity provides health science solutions, technologies, expertise and services that deliver complete workflows from discovery to development, and diagnosis to cure. Revvity is revolutionizing what’s possible in healthcare, with specialized focus areas in translational multi-omics technologies, biomarker identification, imaging, prediction, screening, detection and diagnosis, informatics and more.

With 2023 revenue of more than $2.7 billion and over 11,000 employees, Revvity serves customers across pharmaceutical and biotech, diagnostic labs, academia and governments. It is part of the S&P 500 index and has customers in more than 190 countries.

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Media Relations:

Chet Murray

(781) 462-5126

chet.murray@revvity.com



Investor Relations:

Steve Willoughby

steve.willoughby@revvity.com

Source: Revvity

FAQ

What is the purpose of Revvity's new EURORealTime APOE assay?

The EURORealTime APOE assay is designed for APOE genotyping to assess a patient's risk for side effects before starting anti-amyloid therapy for Alzheimer's disease.

How does the EURORealTime APOE test work?

The test allows simultaneous detection of the three most frequent APOE forms (E2, E3, and E4) using genomic DNA isolated from a single blood sample in one reaction.

What is the significance of APOE E4 in Alzheimer's treatment?

Carriers of exclusively APOE E4 exhibit the highest risk for ARIA (Amyloid-Related Imaging Abnormalities) under anti-amyloid therapy for Alzheimer's disease.

Where is Revvity's APOE genotyping test available?

The EURORealTime APOE assay is available in European countries that accept the CE mark.

How can the EURORealTime APOE test be processed?

The assay processing can be automated on Revvity instruments, including the EUROIMMUN PreNAT II and chemagic 360 platforms, with results evaluated using EURORealTime analysis software.

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