GIST (Tumor estromal gastrointestinal)

Product Name/Description	No. of Reactions*	Product Code
GIST Mutation Screening Panel for Real-Time PCR	44	GIST-RT44

*Includes all controls.

PDGFRA & c-KIT Mutations in GIST
Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors of the GI tract. Over 80% of GISTs harbor activating mutation in c-KIT and approximately 5-7% in PDGFRA. Although these mutations cause tumorigenesis, they also predict response to targeted therapies and provide prognostic information.The GIST Mutation Screening Panel detects the following mutations:

Gene	Mutation
KIT	EX9_p.Y503_F504insAY
KIT	EX11_ p.V559D
KIT	EX11_del
KIT	EX11_p.L576P
KIT	EX11_p.V559A
KIT	EX11_p.V559G
KIT	EX11_p.V560D
KIT	EX11_p.W557G
KIT	EX11_W557R
KIT	EX13_p.K642E
KIT	EX17_p.D816H
KIT	EX17_p.D816V
KIT	EX17_p.D820G
KIT	EX17_p.D820Y
KIT	EX17_p.D820Y
KIT	EX17_p.K818R
KIT	EX17_p.N822H
KIT	EX17_p.N822K
KIT	EX17_p.Y823D
PDGFRA	EX18_p.D842V

Testing Procedure and Analysis

EntroGen’s GIST mutation screening panel is a polymerase chain reaction (PCR)-based assay that uses allele-specific primers to identify the presence of somatic mutations in c-KIT and PDGFRA genes. The testing procedure involves three (3) simple steps:

Isolation of DNA from tumor biopsies, paraffin-embedded sections (FFPE), or fresh frozen tumors
Amplification of regions of the c-KIT and PDGFRA genes using allele-specific primers
Analysis of the captured amplification data.

This test can be completed in approximately 2 hours from isolation of DNA to test result.

Equipment and Materials

EntroGen’s GIST mutation screening panel requires a real-time PCR instrument capable of detecting FAM, VIC, ROX and CY5 fluorescent probes.

This test includes reagents required for the PCR amplification/detection, as well as validated reaction controls. Columns and reagents for DNA isolation are not included.

Intended Use

USA: Available for research use only (RUO). Not for use in diagnostic procedures.

Europe: Available for research (RUO) and diagnostic (CE-IVD) purposes.