We provide an ISO15189 medical laboratory service to physicians and clinical researchers requiring formalin fixed, paraffin embedded (FFPE) tumor tissue DNA molecular characterization. Our capability is supported by a fully automated platform for FFPE tissue DNA extraction, multiplex PCR-based targeted enrichment, library preparation, next-generation sequencing, and gene mutation analysis. This robust workflow increases traceability and reproducibility and improves quality and efficacy of cancer mutation studies. Targeted sequencing of actionable mutations has important implications in cancer diagnosis, prognosis, treatment, and monitoring in the new era of personalized medicine.

Flowchart

 
 

Specimen Requirement

  • Human tissue sections: 3 unstained, positively charged sequential sections from 10% formalin fixed, paraffin embedded (FFPE) tissue block. Preferred tissue fixation is 6-48 hours. Recommended tissue section thickness is 4-5 microns. Tissue sections must be assayed within 6 weeks of preparation.
  • Shipment: tissue sections are kept at room temperature throughout transportation.
 
 

DNA Extraction, Library Preparation, Next-Generation Sequencing, and Gene Mutation Analysis

  • DNA extraction: extract the genomic DNA from FFPE tissue followed by DNA purification and quantification.
  • Library preparation: fragment and size the genomic DNA, enrich multiple PCR-based targets, pool amplicons, and prepare library.
  • Next-generation sequencing: perform targeted sequencing of cancer mutations based on preselected gene panel.
  • Gene mutation analysis: annotate and compare cancer gene mutations including variants with published literatures and public databases.
 
 

Analytical Methods

 
 

Deliverables (Sent within 10 Working Days)

An interpretative report of cancer gene mutations will be provided.
  • Targeted genes used to identify cancer mutations.
  • Sequences of cancer gene mutations and their variants based on next-generation sequencing.
  • Cancer mutation annotation and comparison with known datasets.
  • Additional mutations gene sequencing per customer’s request.
 
 

Services

Cancer Panels

Cancer Genes & Variants

Service Fee

Actionable Insights Tumor Panel V2

ALK
BRAF
EGFR
ERBB2
ERBB3
ESR1

KIT
KRAS
NRAS
PDGFRA
PIK3CA
RAF1

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Actionable Insights Tumor Panel V3

AKT1
ALK
BRAF
CTNNB1
DDR2
EGFR
ERBB2
ERBB3
ERBB4
ESR1
FBXW7
FGFR1
FGFR2
FGFR3
FLT3

GNA11
GNAQ
HRAS
KIT
KRAS
MAP2K1
MAP2K2
MET
NOTCH1
NRAS
PDGFRA
PIK3CA
RAF1
SMAD4
STK11

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Customized Tumor Panel

Upon Request

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For any inquiry, please contact : OEM@abnova.com