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製品
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TruSight Oncology Comprehensive

The first US FDA-approved distributable comprehensive genomic profiling (CGP) IVD with pan-cancer companion diagnostic (CDx) claims.

4～5日

アッセイ時間

約10.5時間

ハンズオンタイム

ゲノムDNA 40 ngおよびトータルRNA 40 ng 

インプット量

仕様タブで詳細を確認する

The product is only available in the US

この製品は出荷できる国が制限されています。 出荷の可否を確認するには、 出荷する国を選択してください 。

Overview

TruSight Oncology Comprehensive is a US FDA-approved next-generation sequencing (NGS)-based CGP IVD for analyzing solid tumors using minimal tissue.

  • Detect DNA plus RNA variants along with biomarker signature TMB

  • Save time and money by assessing multiple biomarkers in a single test

  • Enable targeted therapies and clinical trials with actionable, easy-to-interpret results

Key biomarkers

Content includes key biomarkers associated with major US clinical guidelines, drug labels, and clinical trials.

Companion diagnostic

TruSight Oncology Comprehensive is intended to be used as a companion diagnostic to identify cancer patients who may benefit from treatment with the targeted therapies listed in the table within the intended use statement below, in accordance with the approved therapeutic product labeling.

In-house CGP

Rely on a distributed sample-to-answer solution that can be implemented in-house. Offer precision oncology locally and keep the data and sample in your institution, reducing the likelihood of quantity not sufficient (QNS) issues.

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Intended use

TruSight Oncology Comprehensive is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing to detect variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin embedded (FFPE) tumor tissue samples from cancer patients with solid malignant neoplasms using the Illumina NextSeq 550Dx instrument. The test can be used to detect single nucleotide variants, multi-nucleotide variants, insertions, and deletions from DNA, and fusions in 24 genes and splice variants in one gene from RNA. The test also reports a Tumor Mutational Burden (TMB) score.

The test is intended to be used as a companion diagnostic to identify cancer patients who may benefit from treatment with the targeted therapies listed in Table 1, in accordance with the approved therapeutic product labeling.

In addition, the test is intended to provide tumor profiling information for use by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. Genomic findings other than those listed in Table 1 of the intended use statement are not conclusive or prescriptive for labeled use of any specific therapeutic product.

Table 1: Companion Diagnostics Indications

Tumor Type Biomarker(s) Detected Therapy
Solid Tumors NTRK 1/2/3 fusions VITRAKVI® (larotrectinib)
Non-Small Cell Lung Cancer RET fusions RETEVMO® (selpercatinib)

Specifications

アッセイ時間 4～5日
Content specifications Covers clinically relevant biomarkers across multiple solid tumors included in 53 US clinical guidelines, 60 FDA drug labels, and 860+ US clinical trials. Panel content: 517 genes for small DNA variants, 24 genes for RNA fusions, 1 gene for RNA splice variants (EGFR), and TMB.
Rnaバリアントタイプ別の誤検出率
  • RNA融合遺伝子：0%
  • RNAスプライスバリアント：0%
False positives by dna variant type
  • Small DNA Variants: 0.0001%
  • TMB: not applicable as no clinical threshold has been established.
ハンズオンタイム 約10.5時間
インプット量 ゲノムDNA 40 ngおよびトータルRNA 40 ng 
システム NextSeq 550Dx Instrument
手法 ターゲットDNAシーケンス, ターゲットRNAシーケンス, ターゲット濃縮
核酸の種類 DNA, RNA
サンプルスループット シーケンスランごとに最大患者7例と対照2例（陽性1サンプルとNTC1サンプル）
生物種カテゴリー ヒト
テクノロジー シーケンス

Required products

  • TruSight Oncology Comprehensive, which includes reagents for 24 DNA and 24 RNA library prep and enrichment reactions
  • A one-time purchase of TruSight Oncology Comprehensive Enablement Services is required for training and workflow instruction
  • DNA and RNA controls for monitoring the analytical performance of the assay
  • NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD
  • NextSeq 550Dx Instrument
/ 件

Applications

TruSight Oncology Comprehensive is an in vitro diagnostic test that generates a comprehensive genomic profile of a patient’s tumor, informing therapy decisions according to clinical guidelines.

Example workflow

1
Prep

TruSight Oncology Comprehensive

2
Sequence
3
Analyze

Local Run Manager TruSight Oncology Comprehensive Analysis Module (on-instrument software)

Related applications and methods

Comprehensive genomic profiling

この次世代シーケンサーによるアプローチは、異なる変異型を含む数百のがん関連マーカーを単一のアッセイに統合するものです。

Oncology

イルミナのがん研究向けNGSとマイクロアレイテクノロジーが、がんゲノム分野における革新を牽引します。

Documentation

製品資料
Support documentation

Figures

Fully automated sequencing and data analysis

Batch up to seven patient samples and two control samples per run. Library prep and enrichment take 2 days, followed by a fully automated workflow on the NextSeq 550Dx Instrument. The entire workflow takes 4–5 days.

Variant types and genomic signatures detected

Results report for TruSight Oncology Comprehensive

Reported cancer mutations categorized as cancer mutations with evidence of clinical significance or potential clinical significant based on an expertly curated knowledge base including clinical guidelines, drug labels, clinical trials, and peer-reviewed literature. Easy-to-read output helps increase confidence in treatment decisions.

Resources

サムネール

Introducing TruSight Oncology Comprehensive

TruSight Oncology Comprehensive

20032573

TruSight Oncology Comprehensive kit contains library prep reagents, indexes and panel

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TruSight Oncology DNA Control

20065041

ライブラリー調製、シーケンス、解析の分析性能をモニタリングするための定性的IVDコントロールが含まれます。

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TruSight Oncology RNA Control

20065042

ライブラリー調製、シーケンス、解析の分析性能をモニタリングするための定性的IVDコントロールが含まれます。

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NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles)

20028871

医療機器届出済みNextSeq 550Dxシステムでの300サイクルランをサポートするため、高出力フローセル1個、バッファーカートリッジ1個、クラスター試薬およびシーケンス試薬を含む試薬カートリッジ1個が含まれます。すべての製品が臨床検査用シーケンス試薬として登録されています。

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NextSeq 550 Dx Sequencing System

20005715

NextSeq 550Dx システムは、システムで実行する臨床検査アッセイと併用してDNAライブラリーのシーケンスを行うことを目的としています。NextSeq 550Dx システムは、登録、認証、または承認済みの特定の臨床検査試薬と解析ソフトウェアと共に使用されます。NextSeq 550Dx システムはデュアルオペレーション構成に対応しており、診断（Dx）モードと研究（RUO）モードのいずれでも使用できます。生殖細胞系列バリアントモジュールと体細胞バリアントモジュールを始めとする臨床検査用シーケンスアッセイは、診断モードで実行します。診断モードで利用できるのはIVDシーケンス試薬のみです。

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TSO Comprehensive Enablement Services

20066472

4日間のハンズオントレーニングとワークフロー指示（ライブラリー調製、エンリッチメント、シーケンス、データ解析）を含む、2人までのオペレーターが1回で購入する必要があります。

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FAQs

The test was validated with more than 1400 unique FFPE samples and over 15 different tumor types. Results were compared to orthogonal methods to ensure accurate, reproducible, and consistent data.

Illumina offers a comprehensive support program that provides onboarding to expedite test verification, lab training, verification protocols, training certification, 24/5 technical support, support from our Medical Affairs team for medical inquiries, and educational and marketing assets to share with your local health care providers. Contact your local Illumina Account Manager for more details about the comprehensive support program.

IVD CGP tumor profiling assays with companion diagnostic (CDx) claims across solid neoplasms are covered for eligible Medicare beneficiaries throughout the US under National Coverage Determination (NCD) 90.2. Commercial coverage for assays with this indication increases by more than a third of US commercially insured lives as compared to assays without CDx claims1. Illumina has established a dedicated Market Access team that is actively working with payers to further expand CGP test reimbursement across the globe. Contact your local Illumina Account Manager with questions about coverage.

Illumina has established multiple partnerships with pharma companies to develop a growing pipeline of CDx indications pending regulatory approvals, that include MSI (Bristol Myers Squibb)2, EGFR (Teligene)4, and TP53 (Kartos)5.

The minimum recommended tissue volume is 1 mm3 with a minimum of 20% tumor cell content by area required to detect somatic driver mutations. A minimum of five biopsy slides is recommended (10 µm sections, 20 mm2 tissue area each).

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NextSeq 550Dx High Output Reagent Kit

医療機器届出済みのNextSeq 550Dx システム（届出番号：13B1X10303000001）専用のシークエンス試薬です。これらのシーケンス試薬キットは、臨床検査用にワークフローを簡素化して高いデータ品質を実現します。

NextSeq 550Dx High Output Reagent Kit

医療機器届出済みのNextSeq 550Dx システム（届出番号：13B1X10303000001）専用のシークエンス試薬です。これらのシーケンス試薬キットは、臨床検査用にワークフローを簡素化して高いデータ品質を実現します。

References

  1. Policy Reporter. Data pulled in 2023.
  2. Illumina announces new and expanded oncology partnerships with Bristol Myers Squibb, Kura Oncology, Myriad Genetics, and Merck to advance comprehensive genomic profiling. https://www.businesswire.com/news/home/20210111005930/en/Illumina-Announces-New-and-Expanded-Oncology-Partnerships-with-Bristol-Myers-Squibb-Kura-Oncology-Myriad-Genetics-and-Merck-to-Advance-Comprehensive-Genomic-Profiling. Accessed July 24, 2023.
  3. Illumina partners with Merck to develop and commercialize companion diagnostic and research tests for use in identifying specific cancer mutations. https://www.prnewswire.com/news-releases/illumina-partners-with-merck-to-develop-and-commercialize-companion-diagnostic-and-research-tests-for-use-in-identifying-specific-cancer-mutations-301369838.html. Accessed July 24, 2023.
  4. Illumina and Taolue Biopharmaceuticals Collaborate to Help Chinese Innovation Go Global. https://www.illumina.com.cn/company/news-center/press-releases/2023/648d0d26-1f0a-4b65-b387-2c272761fbd711111.html
  5. Illumina and Kartos Therapeutics Announce New Oncology Partnership to Develop an NGS-Based TP53 Companion Diagnostic. https://www.illumina.com/company/news-center/press-releases/2021/12b6e4a6-3f52-407e-8200-8fa72712a980.html

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