KRAS 5% FFPE Block Tumor Std

Product Overview

This reference standard comprises formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks with a precisely calibrated 5% KRAS mutant allele frequency, mimicking the genetic heterogeneity of clinical patient samples. Manufactured using a proprietary mild fixation protocol and homogeneous paraffin embedding process, the product eliminates variability associated with patient-derived materials, providing consistent performance across multiple assay runs . Each block contains approximately 3 x 10⁸ cells, ensuring sufficient material for multiple extractions and assay validations, making it ideal for clinical laboratories, assay developers, and research institutions focused on oncology diagnostics.

Product Features

Genomic Authenticity

The standard features genetically verified KRAS mutations (including common variants such as G12D, G12V, and G13D) with allelic frequencies quantified by droplet digital PCR (ddPCR), ensuring accuracy within ±30% of the nominal 5% value . This level of precision enables reliable assessment of assay sensitivity for low-frequency mutation detection.

FFPE Matrix Integrity

Processed using 4% PFA fixation and optimized embedding techniques, the FFPE blocks maintain histological integrity comparable to clinical specimens. This preserves high molecular weight DNA (>20kb) that yields ≥400 ng per section using standard extraction protocols like the Promega Maxwell RSC Plus system, facilitating compatibility with downstream molecular assays .

Manufacturing Compliance

Produced in an ISO 13485:2016 certified facility, each batch undergoes rigorous quality control including agarose gel electrophoresis for DNA integrity and Quantifluor™ quantification for concentration accuracy. Comprehensive certificates of analysis (CoA) document genotype confirmation, allelic frequency, and purity metrics .

Usage

Sample Preparation

Section the FFPE block at 5-10 μm thickness using standard microtomy techniques. For optimal results, collect 3-5 consecutive sections per extraction to ensure sufficient DNA yield. Deparaffinize using xylene or commercial deparaffinization reagents followed by ethanol rehydration before DNA extraction.

Assay Validation

The standard supports multiple molecular platforms including NGS panel testing, Sanger sequencing, qPCR, and ddPCR. It is particularly valuable for:

• Establishing limit of detection (LOD) for KRAS mutations

• Verifying workflow integrity from DNA extraction to bioinformatics analysis

• Monitoring inter-assay and intra-assay variability

• Optimizing new cancer detection panels

Storage and Handling

Store unopened blocks at 4°C for up to 36 months from the manufacturing date. Once sectioned, remaining blocks should be wrapped in paraffin film to prevent desiccation. Avoid repeated freeze-thaw cycles as they may compromise DNA integrity .

FAQ

What mutations are present in the KRAS 5% FFPE Block?

The standard contains clinically relevant KRAS mutations including G12D, G12V, G13D, and Q61H, with each variant’s allelic frequency validated by ddPCR. Exact mutations are specified in the product’s CoA.

Is this standard suitable for NGS library validation?

Yes, the standard is fully compatible with NGS workflows. Its high-quality DNA supports library preparation for both targeted panels and whole-exome sequencing, with performance verified across Illumina, Ion Torrent, and PacBio platforms .

How does this product differ from patient-derived FFPE samples?

Unlike patient samples, which exhibit unpredictable variability in fixation quality and cellular composition, this standard offers consistent mutant allele frequency and DNA integrity, enabling reliable assay calibration and quality control .

What is the recommended extraction method?

While compatible with most commercial FFPE DNA extraction kits, we recommend silica-based spin column protocols or automated systems like the Promega Maxwell RSC Plus for optimal yield and purity. Typical extractions yield ≥400 ng DNA per section .

Technical Data