FFPE Reference Standards

| Background and Introduction

GeneWell FFPE reference standards eliminate the variability associated with patient-derived reference standards, and avoid the hassle of sourcing, characterizing, and documenting your own cell line mixes. 

GeneWell FFPE products are all derived from human cell lines. Using a proprietary method of mild fixation and homogenous paraffin embedding, we generate highly-reproducible and consistent FFPE curls. With any commercially available FFPE extraction protocol, our standards yield high molecular weight DNA. This format ensures that they may applied to a wide-range of assays including qPCR, Sanger sequencing, next-generation sequencing, mass array, and more.

The standards are diluted using the corresponding wild type standard to generate a lower allelic frequencies for limit of detection studies and validation of your pre-analytical phase of the workflow.

GeneWell FFPE reference standards cover multiple engineered nucleotide variants (SNVs/SNPs) with clinically-relevant mutations  such as EGFR, KRAS, ALK, MET etc. Batch-specific copy number values measured via ddPCR are provided. 

These FFPE controls contain a series of multiplex and singleplex version available.  Most products centered at 5% allelic frequency and a matched wildtype.

| Product Category

Our FFPEA controls are produced as follows:

  • Structural Multiplex Reference Standards

  • SNVMultiplex Reference Standards

  • Wild Type controls

No. Product Name Product Code Diseases Specification Concentration
1 Onco Fusion Multiplex FFPE(DNA/RNA) Reference Standard IB-GW-RPSM1006 Solid tumor 1 curl/tube N/A
2 Onco Structural Multiplex 5% FFPE Reference Standard IB-GW-OPSM002 Solid tumor 1 curl/tube N/A
3 Onco SNV Multiplex 5% FFPE Reference Standard IB-GW-OPSM003 Solid tumor 1 curl / tube N/A
4 Onco Wildtype FFPE Reference Standard IB-GW-OPSM005 Solid tumor 1 curl / tube N/A
5 5% KRAS G12D FFPE DNA Reference Standard IB-GW-OPSS211 Solid tumor 1 curl / tube N/A
6 5% KRAS Q61H FFPE DNA Reference Standard IB-GW-OPSS215 Solid tumor 1 curl / tube N/A
7 5% EGFR T790M FFPE DNA Reference Standard IB-GW-OPSS204 Solid tumor 1 curl / tube N/A
8 5% EGFR △E746_A750(6223) FFPE DNA Reference Standard IB-GW-OPSS206 Solid tumor 1 curl / tube N/A
9 5% EGFR V769_D770 insASV FFPE DNA Reference Standard IB-GW-OPSS209 Solid tumor 1 curl / tube N/A
10 5% KRAS G12A FFPE DNA Reference Standard IB-GW-OPSS216 Solid tumor 1 curl / tube N/A
11 5% PIK3CA E545K FFPE DNA Reference Standard IB-GW-OPSS229 Solid tumor 1 curl / tube N/A
12 5% PIK3CA H1047R FFPE DNA Reference Standard IB-GW-OPSS230 Solid tumor 1 curl / tube N/A
13 5% NRAS G12V FFPE DNA Reference Standard IB-GW-OPSS238 Solid tumor 1 curl / tube N/A
14 5% NRAS G13D FFPE DNA Reference Standard IB-GW-OPSS239 Solid tumor 1 curl / tube N/A