Prostate Cancer Panel FFPE Reference Standard
Prostate Cancer Panel FFPE Reference Standardは、ISO:13485に準拠して製造された、前立腺がんに臨床的に関連する9遺伝子の16のバリアントを含む、十分に特徴付けられた細胞株由来の精度管理試料です。この革新的なmultigene &multiplex製品により、検査室ははFFPEサンプルを用いた前立腺がんアッセイのバリデーションを迅速かつ信頼性高く、費用対効果の高い方法で実施することができます。さらに、ルーチンの臨床診断に不可欠なFFPEベースのアッセイの性能を評価することができます。他のRevvity Mimix標準サンプルと同様に、診断ワークフローで使用される患者試料を忠実に模倣しています。
バッチ固有の補足的NGSデータ
Prostate Cancer Panel FFPE Reference Standardには、バッチ固有の補足NGSデータが付属しています。VCF ファイルはこちらからアクセスできます。各バッチは、Agilent社のCREV4（Clinical Research Exome）キットを使用し、Illumina社のプラットフォーム上で250 xの深度でシーケンスされ、Illumina社DRAGEN Somatic Pipelineでマッピング、ソート、バリアントコールが行われています。
Technical Data
Format: FFPE
Fixation Method: 4% PFA (w/v)
Section Size: 15µm
Cell Density: 3 x 108 cells per block. Approx. 3.5 x 105 cells per section
Expected DNA Yield: 400 ng using Promega Maxwell RSC FFPE Plus DNA Extraction kit
Genes covered: AR, BRCA1, BRCA2, CDKN2A, PIK3CA, PTEN, RB1, STK11, TP53
Allelic Frequencies: 2.50- 11.00%
Verified Mutations:
| Gene | DNA sequence change |
Amino acid change | Expected allelic frequency (%) |
|---|---|---|---|
| AR | c.2623C>T | p.H875Y | 2.50 |
| AR | c.2632A>G | p.T878A | 2.50 |
| BRCA1 | c.5329dup | p.Q1777Pfs*74 | 6.50 |
| BRCA2 | c.9924C>G | p.Y3308* | 6.00 |
| CDKN2A | c.250G>T | p.D84Y | 7.00 |
| PIK3CA | c.1637A>G | p.Q546R | 6.00 |
| PIK3CA | c.1624G>A | p.E542K | 8.00 |
| PTEN | c.17_18del | p.K6Rfs*4 | 4.00 |
| RB1 | c.2143A>T | p.K715* | 7.00 |
| STK11 | c.532_536del | p.K178fs*86 | 10.00 |
| TP53 | c.992A>G | p.Q331R | 7.00 |
| TP53 | c.742C>T | p.R248W | 11.00 |
| TP53 | c.668C>T | p.P223L | 4.00 |
| TP53 | c.820G>T | p.V274F | 8.00 |
| TP53 | c.414del | p.K139Rfs*31 | 8.00 |
| AR | CNV-Gain | N/A | 5.00 copies |
General information
Storage: 4°C
Shipping: Ambient
Expiration: See all product shelf life information
Intended use: For assay developers, molecular diagnostic labs (Research use only)
Quality control
Allelic frequency: Droplet Digital™ PCR
Quantification: Quantifluor
DNA Integrity: Agarose gel electrophoresis
Manufacturing Quality: ISO 9001:2015 and ISO 13485:2016
We accept orders using the following methods.
Online
Our online catalog and ordering system can be used to search our full menu of available Reference Standards. Select your desired reference standards and add them to the shopping basket. Your order can be submitted instantly using credit card, telephone ordering or a purchase order number as the preferred payment method.
Offline
If you prefer to send us orders outside our online ordering system, please see the Contact Us page for telephone, fax, and email details in order to place an order. We recommend that you use our online system to identify the products you require and their respective “HD” product codes.
To order offline we will require the following information:
- Product code(s) of the item(s) you wish to order (e.g. "HD123")
- Your name, email address, title and organization
- Shipping address and billing address with contact names
- Purchase Order number if you have one
- Telephone number
- VAT Number (European Countries only)
If you’re having trouble ordering or finding what you’re looking for, or if you require something we don’t yet offer, please contact us.
Additional Resources
Certificate of analysis
Safety data sheets
Selection guides
Reference Standards
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At what temperature do you ship reference standards?
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How can I open the NGS data .gz files?
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How do you manufacture your Horizon Reference Standards?
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How do you recommend extracting DNA from an FFPE reference standard?
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How was the batch-specific supplementary NGS data produced and analysed?
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In which formats is the Prostate Cancer Panel DNA Reference Standard available, and do they all contain the PTEN loss variant?
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Is it possible to order custom versions of Horizon Reference Standard?
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Is there a wildtype control in the same background and format as the Prostate Cancer Panel FFPE Reference Standard (HD848)?
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The FFPE yield is lower than expected, how can I improve the yield?
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What batch-specific supplementary NGS data is provided?
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What is the difference between the variants on the CoA and those in the supplementary batch-specific NGS data?
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Where can I access batch-specific supplementary NGS data?
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Which Droplet Digital PCR (ddPCR) system is used for variant detection at Horizon?
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Why do I see different allele frequencies or different variants in my NGS data when comparing to the data provided with the reference standard?