2-in-1 EGFR FFPE Slide Ref Std

Product Overview

The 2-in-1 EGFR FFPE Slide Ref Std is a specialized reference material designed for validating epidermal growth factor receptor (EGFR) mutation detection workflows in non-small cell lung cancer (NSCLC) diagnostics. This pre-cut FFPE slide contains two well-characterized EGFR mutation variants in spatially separated sections, providing a ready-to-use tool for verifying the accuracy of molecular assays used to guide tyrosine kinase inhibitor (TKI) therapy selection. Manufactured to preserve both histological morphology and nucleic acid integrity, this standard addresses the critical need for consistent controls in EGFR testing, where accurate mutation detection directly impacts patient treatment decisions .

Product Features

Clinically Actionable Mutations

Each slide contains two clinically relevant EGFR mutations:

• Exon 19 deletion (E746-A750): The most common EGFR mutation, present at 15% allelic frequency

• L858R point mutation: The second most prevalent variant, present at 12% allelic frequency

Both mutations are verified by NGS (>500x coverage) and ddPCR, ensuring accuracy within ±20% of nominal values .

Precisely Prepared Sections

Each slide features 5 consecutive 10 μm sections mounted on positively charged glass slides to prevent detachment during processing. Sections maintain uniform cellular density (2.5 x 10⁵ cells/section) and preserve tissue architecture for concurrent histopathological review .

Multi-Assay Compatibility

Validated for use with both DNA-based mutation detection methods (qPCR, ddPCR, NGS) and protein expression analysis (IHC). The FFPE matrix preserves both nucleic acids and protein epitopes, enabling comprehensive workflow validation from sectioning through result interpretation .

Usage

Histological Review

Prior to molecular testing, stain one section with Hematoxylin and Eosin (H&E) to:

• Confirm tissue morphology preservation

• Verify section integrity

• Establish appropriate regions for microdissection if needed

DNA Extraction Protocol

Deparaffinize sections using xylene substitute followed by ethanol washes. Perform DNA extraction using silica-based spin columns or automated systems (recommended: QIAamp DNA FFPE Tissue Kit). Typical yields are 80-120 ng DNA per section .

Mutation Detection Validation

Use extracted DNA to validate:

• EGFR mutation assay sensitivity for low-frequency variants

• PCR primer specificity for both deletion and point mutation detection

• NGS library preparation efficiency from FFPE DNA

• Variant calling algorithm performance across different allelic frequencies

FAQ

Why are these specific EGFR mutations included?

Exon 19 deletions and L858R mutations account for approximately 85% of all EGFR mutations in NSCLC and are the primary biomarkers for first-line TKI therapy approval by regulatory agencies including FDA and EMA .

Can this standard be used for both IHC and molecular testing?

Yes, the optimized fixation protocol preserves both EGFR protein epitopes and genomic DNA integrity, allowing simultaneous validation of IHC for protein expression and molecular methods for mutation detection .

How many independent tests can be performed per slide?

Each slide contains sufficient material for 3-4 independent extractions, enabling duplicate or triplicate testing across different assay runs or platforms .

What storage conditions ensure optimal performance?

Store slides at 4°C in a slide box with desiccant for up to 24 months unopened. Once opened, use remaining sections within 4 weeks and maintain storage conditions to prevent tissue degradation .

General information

Technical Data

IHC staining results

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