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EGFR MUTATION ANALYSIS BY PCR

Synonym

therascreen® EGFR RGQ PCR - EGFR

Includes

The therascreen® EGFR RGQ PCR Kit includes the detection of 21 mutations in exons 18, 19, 20, and 21 of the EGFR oncogene against a background of wild type genomic DNA.

Guidelines

therascreen® EGFR RGQ PCR assay is intended to be used to select patients with NSCLC for whom GILOTRIF™ (afatinib), an EGFR tyrosine kinase inhibitor (TKI), is indicated.

Specimen Collection Requirements

Collect

Formalin fix (10 percent neutral buffered formalin) and paraffin embedded tissue. Protect from excessive heat. Transport tissue block or 5 unstained 5-10micron slides. (Minimum 3 slides)

Preferred Volume

FFPE Block or 5 unstained 5-10micron slides

Minimum Volume

3 unstained 5-10micron slides

Transport

Room Temperature

Rejection Criteria

Specimens fixed/processed in alternative fixatives (alcohol, Prefer®),fresh, frozen or decalcified specimens.

Stability

Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable

Testing Information

Performed

Weekly

Method

Real time PCR assay, FDA-approved, Qiagen therascreen® in vitro diagnostics (IVD) kit to detect the 21 mutations in exons 18, 19, 20, and 21 of the EGFR oncogene against a background of wild type genomic DNA.

 

 

Reference Values

Reference Values

No mutation

CPT Codes

81235

Last Updated: Tuesday, November 14, 2017 04:38:13 PM


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