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Pillar oncoReveal CDx is an FDA-approved, NGS-based companion diagnostic kit detecting variants in 22 clinically significant genes in solid tumor DNA.
Pillar product packaging
Pillar product packaging

Pillar oncoReveal CDx

Pillar oncoReveal CDx is an FDA-approved, NGS-based companion diagnostic kit detecting variants in 22 clinically significant genes in solid tumor DNA.

48時間

アッセイ時間

3.5時間

ハンズオンタイム

仕様タブで詳細を確認する

Overview

Pillar oncoReveal CDx is a US FDA-approved, NGS-based pan-cancer solid tumor test with companion diagnostic claims, offering rapid results in a sample-to-clinical report in less than 48 hours. The kit provides clinically actionable information to consider appropriate companion diagnostic (CDx) therapies in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), and to aid in the identification of other clinically significant genomic alternations for patients with solid tumors. The assay uses proprietary stem loop inhibition-mediated amplification SLIMamp technology, a tiled amplicon-based library prep chemistry for efficient single-tube target enrichment.

Key features

  • Assess over 3600 variants in 22 clinically relevant genes across major solid tumor types

  • Detect CDx variants down to 1.5% VAF with input as low as 10 ng DNA

  • Generate easy-to-interpret results in under 48 hours with just 3.5 hours of hands-on time

  • Process up to 46 clinical samples on a single Illumina MiSeqDx Instrument run*

*Using the MiSeqDx Reagent Kit v3.

Broad clinical utility

NGS-based IVD companion diagnostic test identifies patients who may benefit from targeted therapies for NSCLC and CRC, and for general tumor profiling across 22 genes for patients diagnosed with solid malignant neoplasms. 

Rapid clinical results

Single tube workflow enables localized testing by most clinical laboratories, requiring just ~3.5 hours of hands-on time with multiple optional stopping points. The assay includes an integrated, easy-to-interpret clinical report available within 48 hours.

Scalable testing

Batches of up to 46 clinical samples can be processed with high assay sensitivity using the Illumina MiSeqDx Instrument, allowing clinical labs to offer NGS testing within a clinically actionable timeframe.

Intended use

Pillar oncoReveal CDx is a qualitative next generation sequencing-based in vitro diagnostic test that uses amplicon-based target enrichment technology for detection of single nucleotide variants (SNVs), insertions and deletions in 22 genes using DNA isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens and using the Illumina MiSeqDx Instrument. The test is intended as a companion diagnostic to identify patients who may benefit from treatment with the targeted therapies listed in the table below in accordance with the approved therapeutic product labeling. 

Additionally, Pillar oncoReveal CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for previously diagnosed cancer patients with solid malignant neoplasms. Genomic findings other than those listed in the table below are not prescriptive or conclusive for labeled use of any specific therapeutic product. 

Table: Approved companion diagnostic and tumor profiling indications

Tumor Types Biomarkers Targeted therapy
Colorectal Cancer (CRC) KRAS wild-type (absence of mutations in codons 12 and 13) Erbitux (cetuximab), or Vectibix (panitumumab)
Non-Small Cell Lung Cancer (NSCLC) EGFR Exon 19 In Frame Deletions and Exon 21 L858R Substitution Mutations EGFR Tyrosine Kinase Inhibitors approved by FDA
Pan-cancer solid tumors (CRC, NSCLC, breast, melanoma, ovarian, endometrial, renal, liver, bladder, thyroid, pancreatic, brain, and other) General tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for cancer patients with solid malignant neoplasms.

Specifications

アッセイ時間 48時間
ハンズオンタイム 3.5時間
システム MiSeqDx Instrument
手法 ターゲットDNAシーケンス, アンプリコンシーケンス
核酸の種類 DNA
生物種カテゴリー ヒト
テクノロジー シーケンス

Required Products

The following products are required for use of Pillar oncoReveal CDx:

  • Pillar oncoReveal CDx kit (HDA-LC-2001-48)

  • MiSeqDx Instrument (DX-410-1001)

  • MiSeqDx Reagent Kit v3 (20037124)

  • Pillar oncoReveal CDx PiVAT workstation (SFW-2012)

  • Pillar oncoReveal CDx Enablement Services (20132976), required for first time purchase only

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Applications

Pillar oncoReveal CDx is an FDA-approved, NGS-based, companion diagnostic test that interrogates 22 clinically actionable genes from solid tumor samples, offering an easy-to-interpret clinical report in under 48 hours.  

Example workflow

1
Prep

Pillar oncoReveal CDx

2
Sequence
3
Analyze

Pillar oncoReveal CDx PiVAT workstation

Documentation

製品資料
Support documentation

Figures

Pillar oncoreveal CDx approved indications

Approved companion diagnostic and tumor profiling indications

Approved indications of Pillar oncoReveal CDx for patients previously diagnosed with solid tumors. 

Pillar oncoreveal CDx gene list

Pillar oncoReveal CDx gene list

List of the 22 genes approved for Pillar oncoReveal CDx interrogation. 

Pillar oncoreveal CDx tech specs

Pillar oncoReveal technical specifications

Detailed specifications for Pillar oncoReveal CDx.

サービス (1)

oncoReveal Dx Pan-Cancer Solid Tumor IVD Enablement Services

20132976

The oncoReveal™CDx Pan-Cancer Solid Tumor IVD Enablement Services is a one-time mandatory purchase that includes a comprehensive suite of activities for implementing the IVD Solution. This package provides hands-on training led by an Illumina-certified FAS, covering library preparation, sequencing, and data analysis. The training is delivered over 4 days and supports up to 2 operators.

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ライブラリー調製 (1)

oncoReveal CDx Pan-Cancer Solid Tumor IVD.

HDA-LC-2001-48

22 gene (46 sample) solid tumor IVD DNA panel on SLIMamp™ workflow

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データ解析および保存 (1)

OncoReveal™ PiVAT Workstation

SFW-2012

IVD software to support the oncoReveal™ DX lung and Colon Cancer Assay.

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装置 (1)

MiSeqDx™ システム

DX-410-1001

MiSeqDx システムには、タッチスクリーンモニターと装置内蔵コンピューター、デュアルサーフェスイメージング機能、MiSeq Software Suite、インストールキット、装置の設置とトレーニングに加え、ブリッジ増幅、シーケンス、一次および二次解析によるDNAクローンクラスターの自動生成をサポートする12か月の保証（部品と工賃を含む）が含まれます。適格性評価サービス、装置サービスプラン、試薬キットは別売りです。

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試薬 (1)

MiSeqDx 試薬キット（MiSeq Dx Reagent Kit v3）

20037124

MiSeqDxシステム上でのサンプルライブラリーラン1回をサポートするためのフローセル1個と、クラスター試薬およびシーケンス試薬を含むプレフィルドカートリッジ1個が含まれます。

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FAQs

Each Pillar oncoReveal CDx kit contains reagents to process 48 total reactions, supporting the processing of up to 46 clinical samples on a single MiSeqDx Instrument run using the MiSeqDx Reagent Kit v3.

Pillar oncoReveal CDx requires 10–30 ng DNA isolated from FFPE tumor samples.

Pillar oncoReveal CDx does not include automation, however the test uses Pillar SLIMamp chemistry which is fast and simple to use.

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MiSeqDx システムのご購入

MiSeqDx システム（届出番号 13B1X10303000002）の価格、在庫、その他のご購入に関するご相談は、当社の担当まで問い合わせください。

MiSeqDx 試薬キット

医療機器届出済みのMiSeqDx システム（届出番号 13B1X10303000002）シーケンス試薬。以前のバージョンと比較して、クオリティスコアが向上しています。

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MiSeqDx 試薬キット

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