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Illumina enhances flagship assay to accelerate access to comprehensive tumor profiling

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Illumina (NASDAQ:ILMN) has launched TruSight Oncology 500 version 2 (TSO 500 v2), an enhanced version of its flagship cancer research assay for comprehensive genomic profiling (CGP). The upgraded assay now includes built-in homologous recombination deficiency (HRD) detection at no additional cost, powered by Myriad Genetics' gold-standard Genomic Instability Scoring algorithm.

Key improvements include a streamlined workflow with reduced turnaround time, lower tissue sample requirements, and enhanced sustainability features including 50% less packaging and 70% fewer tubes. The assay enables comprehensive analysis of hundreds of genes and immuno-oncology biomarkers from small tissue samples to support cancer therapy research and clinical trial eligibility assessment.

Illumina (NASDAQ:ILMN) ha lanciato TruSight Oncology 500 versione 2 (TSO 500 v2), una versione migliorata del suo principale test per la ricerca sul cancro dedicato al profilo genomico completo (CGP). Il test aggiornato include ora la rilevazione integrata della carenza di ricombinazione omologa (HRD) senza costi aggiuntivi, supportata dall'algoritmo di punteggio dell'instabilità genomica di riferimento di Myriad Genetics.

Le principali novità comprendono un flusso di lavoro semplificato con tempi di risposta ridotti, minori requisiti di campioni tissutali e caratteristiche di sostenibilità potenziate, tra cui . Il test consente un'analisi completa di centinaia di geni e biomarcatori immuno-oncologici da piccoli campioni di tessuto, supportando la ricerca sulle terapie oncologiche e la valutazione dell'idoneità ai trial clinici.

Illumina (NASDAQ:ILMN) ha lanzado TruSight Oncology 500 versión 2 (TSO 500 v2), una versión mejorada de su ensayo principal para investigación del cáncer, destinado al perfilado genómico integral (CGP). El ensayo actualizado ahora incluye detección integrada de deficiencia de recombinación homóloga (HRD) sin costo adicional, impulsado por el algoritmo de puntuación de inestabilidad genómica de referencia de Myriad Genetics.

Las mejoras clave incluyen un flujo de trabajo optimizado con tiempos de respuesta reducidos, menores requisitos de muestras de tejido y características mejoradas de sostenibilidad, incluyendo 50% menos embalaje y 70% menos tubos. El ensayo permite un análisis completo de cientos de genes y biomarcadores inmunooncológicos a partir de pequeñas muestras de tejido para apoyar la investigación en terapias contra el cáncer y la evaluación de elegibilidad para ensayos clínicos.

Illumina (NASDAQ:ILMN)는 종합 유전체 프로파일링(CGP)을 위한 주력 암 연구 분석법인 TruSight Oncology 500 버전 2(TSO 500 v2)를 출시했습니다. 이번 업그레이드된 분석법에는 추가 비용 없이 내장된 상동 재조합 결핍(HRD) 탐지 기능이 포함되었으며, 이는 Myriad Genetics의 표준 유전체 불안정성 점수 알고리즘에 기반합니다.

주요 개선 사항으로는 처리 시간을 단축한 간소화된 작업 흐름, 적은 조직 샘플 요구량, 그리고 포장재 50% 감소 및 튜브 70% 감소를 포함한 향상된 지속 가능성 기능이 있습니다. 이 분석법은 소량의 조직 샘플에서 수백 개의 유전자와 면역종양학 바이오마커를 종합적으로 분석하여 암 치료 연구 및 임상 시험 적합성 평가를 지원합니다.

Illumina (NASDAQ:ILMN) a lancé TruSight Oncology 500 version 2 (TSO 500 v2), une version améliorée de son test phare de recherche sur le cancer pour le profilage génomique complet (CGP). Le test amélioré inclut désormais la détection intégrée de la déficience en recombinaison homologue (HRD) sans coût supplémentaire, grâce à l'algorithme de notation de l'instabilité génomique de référence développé par Myriad Genetics.

Les principales améliorations comprennent un flux de travail simplifié avec un délai d'exécution réduit, des besoins en échantillons tissulaires moindres, et des caractéristiques accrues de durabilité, incluant 50 % moins d'emballages et 70 % moins de tubes. Ce test permet une analyse complète de centaines de gènes et biomarqueurs immuno-oncologiques à partir de petits échantillons de tissu, soutenant la recherche sur les thérapies anticancéreuses et l'évaluation de l'éligibilité aux essais cliniques.

Illumina (NASDAQ:ILMN) hat TruSight Oncology 500 Version 2 (TSO 500 v2) vorgestellt, eine verbesserte Version ihres führenden Krebsforschungsassays für umfassendes genomisches Profiling (CGP). Der aktualisierte Assay beinhaltet nun integrierte Erkennung von homologer Rekombinationsdefizienz (HRD) ohne zusätzliche Kosten, basierend auf dem branchenführenden Genominstabilitäts-Scoring-Algorithmus von Myriad Genetics.

Zu den wichtigsten Verbesserungen gehören ein optimierter Arbeitsablauf mit verkürzten Durchlaufzeiten, geringerer Gewebeprobenanforderung und verbesserte Nachhaltigkeitsmerkmale, darunter 50 % weniger Verpackungsmaterial und 70 % weniger Röhrchen. Der Assay ermöglicht die umfassende Analyse von Hunderten von Genen und immunonkologischen Biomarkern aus kleinen Gewebeproben zur Unterstützung der Krebsforschung und der Bewertung der Eignung für klinische Studien.

Positive
  • Integration of HRD biomarker detection at no additional cost
  • Improved workflow efficiency with reduced turnaround time
  • Enhanced sustainability with 50% less packaging and 70% fewer tubes
  • Broader platform compatibility across high and mid-throughput sequencers
  • Improved accuracy compared to competitor solutions
Negative
  • None.

Insights

Illumina's enhanced TSO 500 v2 adds significant value with HRD biomarker integration, faster workflows, and reduced sample requirements.

Illumina's announcement of TruSight Oncology 500 v2 represents a meaningful advancement in their comprehensive genomic profiling (CGP) portfolio. The enhanced assay addresses three critical pain points in cancer research: it now includes built-in homologous recombination deficiency (HRD) detection using Myriad's gold-standard scoring algorithm at no additional cost, requires less tissue input, and delivers faster turnaround times through a streamlined workflow.

The integration of HRD biomarker detection is particularly significant. HRD status helps identify tumors with defects in DNA repair mechanisms, which can inform therapy selection research, especially for PARP inhibitors. By bundling this capability into the base assay, Illumina expands research accessibility into HRD's predictive value beyond ovarian and breast cancers.

The workflow improvements address key laboratory efficiency challenges. The redesigned kit reduces packaging by 50% and tubes by 70%, while color-coding simplifies the user experience. These optimizations directly impact laboratory economics through reduced hands-on time and potential error rates.

Compatibility across Illumina's sequencing platforms coupled with integrated data analysis pathways (via DRAGEN or third-party solutions) creates a comprehensive ecosystem approach. The testimonials from early access customers highlight the real-world validation of these improvements, particularly regarding accuracy improvements over competing solutions.

This product enhancement strengthens Illumina's position in the increasingly competitive precision oncology market while addressing customer needs for more efficient comprehensive genomic profiling tools that can operate at scale.

Illumina TruSight™ Oncology 500 v2 research assay is now available with built-in HRD biomarker detection, faster turnaround time, and lower tissue sample input

Illumina's growing research and clinical oncology portfolio broadens access to critical biomarker testing

SAN DIEGO, July 30, 2025 /PRNewswire/ -- Illumina Inc. (NASDAQ: ILMN) today announced the launch of the next generation of TruSight Oncology 500, its flagship cancer research assay that enables comprehensive genomic profiling. Comprehensive genomic profiling (CGP) is a critical tool to accelerate access to precision medicine by providing a molecular tumor profile to labs advancing research in therapy selection and clinical trial eligibility. TruSight Oncology 500 version 2 (TSO 500 v2) offers a streamlined sample-to-analysis workflow and reflects Illumina's commitment to serving customers with the highest quality and most rigorously tested solutions.

"TSO 500 is a trusted assay used by hundreds of researchers worldwide, and these enhancements deliver even greater value for customers with built-in HRD detection, faster turnaround time, and less tissue required," said Everett Cunningham, chief commercial officer of Illumina. "Customers need complete workflow solutions like this one to enable CGP more efficiently and at scale, ultimately advancing access to tumor profiling and cancer therapy research."

From a small tissue sample, TSO 500 v2 assesses hundreds of genes across all variant classes and immuno-oncology biomarkers to facilitate therapy selection research. Research shows that when CGP is performed early in a cancer patient's diagnosis, it leads to better personalized treatment and outcomes. 

Faster, easier, more efficient workflow

For the first time, homologous recombination deficiency (HRD) status will be included for all samples analyzed, at no additional cost. HRD analysis is powered by a gold-standard Genomic Instability Scoring (GIS) algorithm licensed from Myriad Genetics. This will expand research into the value of the HRD biomarker in more cancer types.

Early-access customer Weiyi Chen, PhD, HCLD (ABB), technical director, Molecular Diagnostics at siParadigm Diagnostic Informatics, noted the assay's distinct advantages.

"We are very excited about the launch of TSO 500 v2. We found improved accuracy of data results with TSO 500 v2 compared to our current solution from a different vendor," said Chen.   "The new workflow is fast and streamlined with HRD included. Turnaround time is very important to our lab so we can quickly access results. The solution will also allow us to minimize service costs by consolidating our tests on Illumina sequencers."

Key advantages included in TSO 500 v2:

  • Streamlined workflow reduces turnaround time and hands-on time

  • Sensitive variant calling and improved coverage of difficult genomic regions

  • Leverages gold-standard Myriad® Genomic Instability Score (GIS) algorithm to determine HRD status, included for all samples

  • Improved sustainability: New kit configurations with 50% less packaging, 70% fewer tubes, and improved usability with a color-coded tubing system

  • Integrated and automated data analysis, from sequencer to insights, supported with DRAGEN secondary analysis and Illumina Connected Insights for variant interpretation, or with third-party solutions like Velsera Clinical Genomics Workspace (CGW)

  • Broad platform compatibility across high- and mid-throughput sequencers

  • User-friendly automation kits and methods (coming soon) that further reduce turnaround time and hands-on time compared to the manual workflow

Another early access customer, Conxi Lázaro, PhD, lab director at the Catalan Institute of Oncology, noted the impact of the updated packaging and kit configuration on the user experience: "There are far fewer boxes and tubes to manage, which means we spend less time unboxing and can work faster and more efficiently. Now that the tubes are color coded, there is less room for error, and it is much easier to track the different steps in the workflow."

Illumina's oncology portfolio

Illumina has established and continues to invest in research and clinical solutions to bring advanced tumor profiling technologies to scale and address customers' broad range of biomarker profiling needs.

The TruSight Oncology portfolio encompasses research-use-only (TSO 500 products) and in vitro diagnostic (TSO Comprehensive) solutions across a range of mid- and high-throughput instrumentation. 

Through a partnership with Pillar BioSciences, Illumina also offers customers targeted molecular profiling tests. Earlier this year, Illumina announced the addition of the Pillar oncoReveal CDx IVD kit to its portfolio. The kit will be available to order later this quarter.

Learn more about TSO 500 v2.

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, manufacturing, and launching new products and services; (ii) customer uptake of, and satisfaction with, new products and services; (iii) our ability to manufacture robust instrumentation and consumables; (iv) the future conduct and growth of the business and the markets in which we operate; and (v) legislative, regulatory and economic developments, 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.

Contacts
Investors:
Brian Blanchett
IR@illumina.com

Media:
Christine Douglass
PR@illumina.com

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SOURCE Illumina, Inc.

FAQ

What are the key improvements in Illumina's TruSight Oncology 500 v2 (TSO 500 v2)?

The key improvements include built-in HRD biomarker detection, faster turnaround time, lower tissue sample requirements, and a streamlined workflow with 50% less packaging and 70% fewer tubes.

How does TSO 500 v2 enhance cancer research capabilities?

TSO 500 v2 assesses hundreds of genes across all variant classes and immuno-oncology biomarkers from small tissue samples, facilitating therapy selection research and clinical trial eligibility assessment.

What is the significance of HRD detection in Illumina's TSO 500 v2?

The built-in HRD detection, powered by Myriad's gold-standard Genomic Instability Scoring algorithm, enables expanded research into HRD biomarker value across multiple cancer types at no additional cost.

How does TSO 500 v2 improve laboratory workflow efficiency?

The assay features a streamlined sample-to-analysis workflow with reduced turnaround time, color-coded tubing system, automated data analysis, and upcoming automation kits for further efficiency improvements.

What platform compatibility does Illumina's TSO 500 v2 offer?

TSO 500 v2 offers broad compatibility across high and mid-throughput sequencers, with integrated data analysis supported by DRAGEN secondary analysis and Illumina Connected Insights or third-party solutions.
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