Revvity and Element Biosciences Collaborate to Advance Sequencing-based IVD Neonatal Testing
Revvity (NYSE: RVTY) has announced a strategic agreement with Element Biosciences to develop and commercialize an in vitro diagnostic (IVD) workflow solution for neonatal sequencing. The collaboration combines Revvity's expertise in newborn screening and rare disease detection with Element's AVITI™ sequencing system technology.
The partnership will deliver both an immediate research use only (RUO) version and a comprehensive IVD solution for newborn sequencing. The workflow includes Revvity's sample collection devices, dried blood spot punchers, automated nucleic acid extractors, liquid handlers, NGS library preparation kits with curated NGS panels, and software for variant calling data analysis and interpretation.
This initiative builds upon Revvity's recent introduction of an automated next-generation sequencing workflow for newborn sequencing research and supports Element's progress toward regulatory approval of their benchtop AVITI™ sequencing system.
Revvity (NYSE: RVTY) ha annunciato un accordo strategico con Element Biosciences per sviluppare e commercializzare una soluzione di flusso di lavoro diagnostico in vitro (IVD) per il sequenziamento neonatale. La collaborazione unisce l'expertise di Revvity nello screening neonatale e nella rilevazione di malattie rare con la tecnologia del sistema di sequenziamento AVITI™ di Element.
La partnership fornirà sia una versione immediata per utilizzo della ricerca (RUO) sia una soluzione IVD completa per il sequenziamento neonatale. Il flusso di lavoro include dispositivi per la raccolta dei campioni di Revvity, perforatori per punti di sangue secco, estrattori automatizzati di acidi nucleici, gestori di liquidi, kit di preparazione di librerie NGS con pannelli NGS curati e software per l'analisi dei dati e l'interpretazione delle varianti.
Questa iniziativa si basa sull'introduzione recente da parte di Revvity di un flusso di lavoro automatizzato di sequenziamento di nuova generazione per la ricerca sul sequenziamento neonatale e supporta i progressi di Element verso l'approvazione normativa del loro sistema di sequenziamento AVITI™ da banco.
Revvity (NYSE: RVTY) ha anunciado un acuerdo estratégico con Element Biosciences para desarrollar y comercializar una solución de flujo de trabajo de diagnóstico in vitro (IVD) para el secuenciación neonatal. La colaboración combina la experiencia de Revvity en la detección de enfermedades raras y el cribado neonatal con la tecnología del sistema de secuenciación AVITI™ de Element.
La asociación proporcionará tanto una versión inmediata solo para investigación (RUO) como una solución IVD completa para el secuenciación neonatal. El flujo de trabajo incluye dispositivos de recolección de muestras de Revvity, perforadores de puntos de sangre seca, extractores automatizados de ácidos nucleicos, manipuladores de líquidos, kits de preparación de bibliotecas NGS con paneles NGS curados y software para el análisis de datos de variantes e interpretación.
Esta iniciativa se basa en la reciente introducción de un flujo de trabajo automatizado de secuenciación de nueva generación de Revvity para la investigación del secuenciamiento neonatal y apoya el progreso de Element hacia la aprobación regulatoria de su sistema de secuenciación AVITI™ de banco.
Revvity (NYSE: RVTY)는 Element Biosciences와 협력하여 신생아 시퀀싱을 위한 체외 진단(IVD) 워크플로우 솔루션을 개발하고 상용화하는 전략적 협약을 발표했습니다. 이 협업은 신생아 선별 검사와 희귀 질병 탐지에 대한 Revvity의 전문성을 Element의 AVITI™ 시퀀싱 시스템 기술과 결합합니다.
이번 파트너십은 연구 전용(RUO) 즉시 사용 버전과 신생아 시퀀싱을 위한 포괄적인 IVD 솔루션을 제공합니다. 워크플로우에는 Revvity의 샘플 수집 장치, 건조 혈액 점 표적, 자동 핵산 추출기, 액체 처리기, 큐레이션된 NGS 패널이 포함된 NGS 라이브러리 준비 키트, 변이 호출 데이터 분석 및 해석을 위한 소프트웨어가 포함됩니다.
이번 이니셔티브는 신생아 시퀀싱 연구를 위한 자동화된 차세대 시퀀싱 워크플로우의 Revvity의 최근 도입을 기반으로 하며, Element의 벤치탑 AVITI™ 시퀀싱 시스템의 규제 승인 진행을 지원합니다.
Revvity (NYSE: RVTY) a annoncé un accord stratégique avec Element Biosciences pour développer et commercialiser une solution de flux de travail de diagnostic in vitro (IVD) pour le séquençage néonatal. La collaboration combine l'expertise de Revvity en matière de dépistage des nouveau-nés et de détection des maladies rares avec la technologie du système de séquençage AVITI™ d'Element.
Le partenariat fournira à la fois une version immédiate à des fins de recherche (RUO) et une solution IVD complète pour le séquençage des nouveau-nés. Le flux de travail comprend des dispositifs de collecte d'échantillons de Revvity, des perforateurs de points de sang sec, des extracteurs automatiques d'acides nucléiques, des manipulateurs de liquides, des kits de préparation de bibliothèques NGS avec des panneaux NGS sélectionnés, ainsi qu'un logiciel pour l'analyse et l'interprétation des données de variants.
Cette initiative s'appuie sur la récente introduction par Revvity d'un flux de travail automatisé de séquençage de nouvelle génération pour la recherche sur le séquençage néonatal et soutient les progrès d'Element vers l'approbation réglementaire de leur système de séquençage AVITI™ de banc.
Revvity (NYSE: RVTY) hat eine strategische Vereinbarung mit Element Biosciences angekündigt, um eine In-vitro-Diagnostik-(IVD)-Workflow-Lösung für die Neugeborenensequenzierung zu entwickeln und zu kommerzialisieren. Die Zusammenarbeit kombiniert Revvitys Fachwissen in der Neugeborenenscreening und der Erkennung seltener Krankheiten mit der Technologie des AVITI™-Sequenzierungssystems von Element.
Die Partnerschaft wird sowohl eine sofortige Forschungsnutzung (RUO)-Version als auch eine umfassende IVD-Lösung für die Neugeborenensequenzierung bereitstellen. Der Workflow umfasst Revvitys Probenahmegeräte, Perforatoren für trockene Blutproben, automatisierte Nukleinsäureextraktoren, Flüssigkeitshandler, NGS-Bibliotheksvorbereitungskits mit kuratierten NGS-Panels und Software zur Analyse und Interpretation von Variantendaten.
Diese Initiative baut auf Revvitys kürzlicher Einführung eines automatisierten Workflows zur Sequenzierung der nächsten Generation für die Neugeborenensequenzierungsforschung auf und unterstützt die Fortschritte von Element in Richtung der behördlichen Genehmigung ihres benchtop AVITI™-Sequenzierungssystems.
- Strategic expansion into IVD neonatal testing market
- Immediate revenue potential through RUO version availability
- Development of end-to-end comprehensive testing solution
- Progress towards regulatory approval for AVITI™ system
- Regulatory approval timeline and success uncertain
- Development and commercialization costs not disclosed
Insights
The strategic partnership between Revvity and Element Biosciences marks a pivotal advancement in neonatal diagnostic testing. The collaboration integrates Revvity's established newborn screening expertise with Element's AVITI sequencing platform, creating a comprehensive in vitro diagnostic (IVD) workflow solution for neonatal sequencing.
The partnership's commercial significance lies in three key areas:
- Market expansion into the regulated IVD space, representing a larger addressable market compared to research-only applications
- Creation of a complete end-to-end workflow solution that includes sample collection, processing, sequencing and analysis
- Potential first-mover advantage in the NGS-based neonatal IVD testing market
For Revvity, this represents a strategic expansion of their diagnostics portfolio and positions them to capture a larger share of the growing molecular diagnostics market, estimated to reach
The regulatory implications of this partnership are substantial. The development of an IVD workflow solution requires extensive validation and regulatory submissions to obtain FDA clearance and CE marking for European markets. The immediate availability of a Research Use Only (RUO) version allows both companies to generate valuable real-world data while pursuing regulatory approvals.
The strategic approach of launching an RUO version first is a common and prudent regulatory pathway that:
- Enables data collection for regulatory submissions
- Allows workflow optimization based on user feedback
- Establishes market presence while pursuing approvals
The transition from RUO to IVD status typically takes 18-24 months, suggesting potential commercialization of the IVD version by 2026-2027. This timeline aligns well with increasing adoption of NGS-based testing in clinical diagnostics.
The collaboration involves the co-development of a comprehensive IVD solution tailored for newborn sequencing. Additionally, customers will have immediate access to a research use only (RUO) version of the newborn sequencing research workflow.
"This strategic endeavor represents a significant step forward in our commitment to advancing newborn health through innovative genomic technologies," said Yves Dubaquie, senior vice president, diagnostics at Revvity. "By combining our expertise in newborn screening and rare disease detection with Element’s technological capabilities, Revvity aims to deliver a robust, efficient, and accessible solution for neonatal sequencing in both research and clinical settings."
The new IVD solution offered by Revvity will be an important organic next step for each company, expanding the reach of both Element’s AVITI sequencing system and Revvity's newborn sequencing research workflow, which includes its sample collection devices, dried blood spot punchers, automated nucleic acid extractors, liquid handers, NGS library preparation kits with carefully curated NGS panels, and comprehensive software for variant calling data analysis and interpretation. The combined technologies will provide an end-to-end solution for the NGS continuum that supports pioneering neonatal research and the necessary approvals for a cutting-edge IVD in this field.
“Collaboration with Revvity on this IVD solution will provide a comprehensive, high-quality offering that meets the unique needs of newborn screening programs worldwide,” said Yaron Hakak, senior vice president of corporate and business development at Element. “Element is committed to seeking AVITI’s regulatory approval to enable the introduction of new diagnostic solutions from Revvity and other market leading partners.”
For more information about Revvity's newborn sequencing research solutions, please visit: https://www.revvity.com/gb-en/category/newborn-sequencing-research
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
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About Element Biosciences, Inc.
Element Biosciences is a pioneering life science company democratizing access to advanced biological tools, driving impactful discoveries to benefit humanity. We are focused on developing disruptive DNA sequencing and multi-omics technology for research markets. Through innovating every fundamental element of a biological assay system, Element empowers customers with affordable, high-quality data and an improved user experience, which in turn will accelerate scientific discoveries. To learn more about Element, please visit www.elementbiosciences.com and follow us on LinkedIn, X (Twitter), and Facebook.
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Revvity Investor Relations:
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steve.willoughby@revvity.com
Revvity Media Relations:
Chet Murray
(781) 462-5126
chet.murray@revvity.com
Element Media Relations:
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Source: Revvity
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