Illumina announces expansion of TruSight Oncology portfolio
Illumina announced the upcoming release of TruSight Oncology 500 v2 (TSO 500 v2), an enhanced version of its cancer research assay for comprehensive genomic profiling, planned for mid-2025. The new version features faster turnaround time, improved coverage, and includes the Myriad Genomic Instability Score for all samples. Key improvements include 50% less packaging, 70% fewer tubes, and better usability. The assay will be compatible with multiple platforms and offer integrated data analysis through DRAGEN and other solutions. Early access feedback from UC San Diego highlights the assay's improved workflow and lower DNA/RNA input requirements.
Illumina ha annunciato il prossimo rilascio di TruSight Oncology 500 v2 (TSO 500 v2), una versione migliorata del suo saggio per la ricerca sul cancro per la profilazione genomica completa, prevista per metà del 2025. La nuova versione presenta un tempo di risposta più rapido, una copertura migliorata e include il Myriad Genomic Instability Score per tutti i campioni. I miglioramenti chiave includono il 50% in meno di imballaggio, il 70% in meno di tubi e una migliore usabilità. Il saggio sarà compatibile con più piattaforme e offrirà un'analisi dei dati integrata tramite DRAGEN e altre soluzioni. I feedback in accesso anticipato da UC San Diego evidenziano il flusso di lavoro migliorato del saggio e minori requisiti di input di DNA/RNA.
Illumina anunció el próximo lanzamiento de TruSight Oncology 500 v2 (TSO 500 v2), una versión mejorada de su ensayo de investigación del cáncer para el perfil genómico completo, programada para mediados de 2025. La nueva versión presenta un tiempo de respuesta más rápido, una cobertura mejorada e incluye el Myriad Genomic Instability Score para todas las muestras. Las mejoras clave incluyen un 50% menos de embalaje, un 70% menos de tubos y una mejor usabilidad. El ensayo será compatible con múltiples plataformas y ofrecerá análisis de datos integrados a través de DRAGEN y otras soluciones. Los comentarios sobre el acceso anticipado de UC San Diego destacan el flujo de trabajo mejorado del ensayo y los menores requisitos de entrada de ADN/ARN.
Illumina는 TruSight Oncology 500 v2 (TSO 500 v2)의 출시를 발표했습니다. 이는 포괄적인 유전체 프로파일링을 위한 암 연구 분석의 향상된 버전으로, 2025년 중반에 출시될 예정입니다. 새로운 버전은 더 빠른 처리 시간과 개선된 커버리지를 제공하며, 모든 샘플에 대해 Myriad Genomic Instability Score를 포함합니다. 주요 개선 사항으로는 포장 재료 50% 감소, 튜브 70% 감소 및 향상된 사용성을 포함합니다. 이 분석은 여러 플랫폼과 호환되며, DRAGEN 및 기타 솔루션을 통해 통합 데이터 분석을 제공합니다. UC 샌디에이고의 조기 접근 피드백은 이 분석의 향상된 워크플로우와 낮은 DNA/RNA 입력 요구 사항을 강조합니다.
Illumina a annoncé la prochaine sortie de TruSight Oncology 500 v2 (TSO 500 v2), une version améliorée de son test de recherche sur le cancer pour le profilage génomique complet, prévue pour la mi-2025. La nouvelle version présente un temps de réponse plus rapide, une couverture améliorée et inclut le Myriad Genomic Instability Score pour tous les échantillons. Les améliorations clés comprennent 50 % d'emballage en moins, 70 % de tubes en moins et une meilleure facilité d'utilisation. Le test sera compatible avec plusieurs plateformes et proposera une analyse de données intégrée via DRAGEN et d'autres solutions. Les retours du programme d'accès anticipé de l'UC San Diego soulignent le flux de travail amélioré du test et les besoins réduits en entrée d'ADN/ARN.
Illumina hat die bevorstehende Veröffentlichung von TruSight Oncology 500 v2 (TSO 500 v2) angekündigt, einer verbesserten Version ihres Krebsforschungsassays zur umfassenden genomischen Profilierung, die für Mitte 2025 geplant ist. Die neue Version bietet schnellere Bearbeitungszeiten, verbesserte Abdeckung und umfasst den Myriad Genomic Instability Score für alle Proben. Zu den wesentlichen Verbesserungen gehören 50% weniger Verpackungsmaterial, 70% weniger Röhrchen und eine bessere Benutzerfreundlichkeit. Der Assay wird mit mehreren Plattformen kompatibel sein und eine integrierte Datenanalyse über DRAGEN und andere Lösungen anbieten. Das frühe Feedback von UC San Diego hebt den verbesserten Workflow des Assays und die geringeren Anforderungen an DNA/RNA-Eingaben hervor.
- Development of enhanced cancer research assay with improved efficiency and coverage
- Reduction in packaging (50%) and tubes (70%), improving operational efficiency
- Integration of Myriad Genomic Instability Score as standard feature
- FDA approval of TSO Comprehensive test with two companion diagnostic indications
- New product won't be available until mid-2025
Insights
The announced TruSight Oncology 500 v2 represents a significant advancement in comprehensive genomic profiling (CGP) technology, though its planned release in mid-2025 means no immediate revenue impact. Key technical improvements include faster processing times, enhanced variant detection and integration of Myriad's HRD scoring system.
The platform's compatibility with various throughput levels and reduced operational complexity (50% less packaging, 70% fewer tubes) should appeal to both research and clinical laboratories. The early access feedback from UC San Diego validates the improvements in workflow efficiency and sample processing capabilities.
While this update strengthens Illumina's position in the competitive oncology diagnostics market, particularly following their recent FDA approval for TSO Comprehensive, the extended timeline to market release suggests minimal near-term financial impact. The technology advancements could help defend market share against emerging competitors, but revenue benefits won't materialize until late 2025.
The latest solution to enable comprehensive genomic profiling of tumors will be presented at the annual meeting of the Association of Molecular Pathology
Customer-led research and presentations at the conference will deliver the latest evidence and education in tumor profiling
TSO 500 v2 assesses hundreds of genes across all variant classes, and immuno-oncology biomarkers, in a single assay from one sample, to facilitate therapy selection research.
Key features of TSO 500 v2 include:
- Faster turnaround time and reduced hands-on time
- Sensitive variant calling and improved coverage of difficult genomic regions
- Gold-standard Myriad® Genomic Instability Score (GIS) to determine homologous recombination deficiency (HRD) status, included for all samples
- New kit configurations with
50% less packaging,70% fewer tubes, and improved usability - Automation methods available with flexible batch sizes
- Integrated and automated data analysis, from sequencer to insights supported with DRAGEN™ secondary analysis and Illumina Connected Insights, or Velsera's Clinical Genomics Workspace (CGW)
- Broad platform compatibility
At AMP, several abstracts accepted for poster presentations will demonstrate preliminary analytical performance data and automation compatibility of TSO 500 v2. The studies support the assay's applications for clinical research in identifying rare genetic biomarkers and fusion biomarkers.
TSO 500 v2 early access customer response
Wei Song, MD, PhD, director of Clinical Genomics and Molecular Pathology at the University of
"We are excited to assess the new features of the TruSight Oncology 500 v2 tissue assay, such as the faster workflow, improved coverage, and lower DNA/RNA input levels," he said. "Such improvements are highly relevant to clinical research laboratories and can positively affect time to results, quality of results, and the processing of challenging tissue samples."
TruSight Oncology portfolio enables clinical research and in-vitro diagnostic CGP solutions
Illumina's oncology portfolio has evolved over time to fit customers' diverse needs for versatility and scalability. The TSO portfolio encompasses research-use-only (TSO 500 products) and in-vitro diagnostic (TSO Comprehensive) solutions across a range of low-, mid-, and high-throughput instrumentation. Illumina also announced today that TSO Comprehensive kits are now available to ship. In August, the company announced FDA approval of its TSO Comprehensive test and its first two companion diagnostic indications.
"In listening to our broad range of customers, we understand there are different needs for biomarker profiling, and Illumina has successfully introduced a continuum of solutions to address varying levels of need," said Traci Pawlowski, vice president of Clinical Solutions at Illumina.
CGP is a critical tool for identifying actionable alterations, including rare mutations, which enables precision medicine in accordance with professional guidelines. At AMP, several customer-led poster presentations will provide further evidence for the clinical utility of CGP and demonstrate its versatility in hospital and community oncology care settings.
Illumina will cohost a workshop with Bayer, featuring a panel discussion of key opinion leaders on the challenges and practice gaps in precision medicine implementation, and the coordination of a multidisciplinary team to ensure optimal biomarker detection and targeted therapy utilization.
For a list of Illumina workshops and presentations at AMP, visit the company's events page.
Use of forward-looking statements
This release may contain forward-looking statements that involve risks and uncertainties. Among the important factors to which our business is subject that could cause actual results to differ materially from those in any forward-looking statements are: (i) challenges inherent in developing and launching new products and services, including modifying and scaling manufacturing operations, and reliance on third-party suppliers for critical components; (ii) our ability to manufacture robust instrumentation and consumables; and (iii) the acceptance by customers of our newly launched products, which may or may not meet our and their expectations, together with other factors detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We undertake no obligation, and do not intend, to update these forward-looking statements, to review or confirm analysts' expectations, or to provide interim reports or updates on the progress of the current quarter.
About Illumina
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as a global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit illumina.com and connect with us on X, Facebook, LinkedIn, Instagram, TikTok, and YouTube.
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SOURCE Illumina, Inc.
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