Medical Devices

therascreen® EGFR RGQ PCR Kit - P120022

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Image of therascreen® EGFR RGQ PCR Kit

Product Name: therascreen® EGFR RGQ PCR Kit
PMA Applicant: QIAGEN Manchester Ltd
Address: Skelton House, Lloyd Street North, Manchester M15 6SH, United Kingdom

Approval Date: July 12, 2013
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf12/P120022a.pdf

What is it? The therascreen® EGFR RGQ PCR Kit is an automated molecular assay designed to detect the presence of mutations in the epidermal growth factor receptor (EGFR) gene in non-small cell lung cancer (NSCLC). In normal tissue, the EGFR protein transmits signals in cells to regulate cell growth and cell death. Mutations in the EGFR gene result in abnormal functioning of the EGFR protein and stimulate cancer cell growth in NSCLC.

GILOTRIF™ (afatinib) is a drug used to treat patients with NSCLC. GILOTRIF™ (afatinib) is an EGFR inhibitor that blocks the abnormal function of the mutant EGFR protein. This test is used to aid physicians in selecting patients with NSCLC for treatment with GILOTRIF™ (afatinib). If the test results indicate that EGFR exon 19 deletion or exon 21 (L858R) substitution mutation is present in NSCLC cells, then the patient may be considered for treatment with GILOTRIF™ (afatinib).

How does it work?

  • The doctor takes a small amount of tumor tissue from a patient’s NSCLC and examines it (biopsy).
  • The tumor tissue is embedded in a block of paraffin wax. A thin slice of the tumor tissue is cut from the block for use in the test.
  • DNA is isolated from a patient’s tumor cells and mixed with reagents that specifically detect, bind to, and make copies of the tumor’s EGFR gene. This reaction produces fluorescence, which is then measured to determine presence or absence of the specific EGFR mutations in a tumor sample.
  • The presence of specific mutations in the EGFR gene indicates that a patient is eligible for treatment with GILOTRIF™ (afatinib).

When is it used? To determine if a patient’s NSCLC characteristics suggest that a patient might be a candidate for GILOTRIF™ (afatinib) treatment.

What will it accomplish? The therascreen® EGFR RGQ PCR Kit helps to determine whether patients with NSCLC should be considered for treatment with GILOTRIF™ (afatinib), which may prolong their life.

When should it not be used? There are no known contraindications.

Additional information: The Summary of Safety and Effectiveness Data and labeling are available.

Page Last Updated: 08/07/2014
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