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Medical Devices

therascreen KRAS RGQ PCR Kit - P110027

Picture of the device.

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.

Product Name: therascreen KRAS RGQ PCR Kit
PMA Applicant: QIAGEN Manchester, Ltd.
Address: Skelton House, Lloyd Street North, Manchester M15 6SH UK
Approval Date: May 23, 2014
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110027a.pdf

What is it? The therascreen KRAS RGQ PCR Kit is an automated molecular assay designed to detect the presence of seven mutations in the K-ras gene in colorectal cancer cells.  In normal tissue, the K-ras protein transmits signals in cells to regulate cell growth and cell death. In colorectal cancer tissue, mutations in the K-ras gene cause an altered form of the K-ras protein and results in abnormal functioning of the protein.

Vectibix (panitumumab) is a drug used to treat patients with colorectal cancer. The presence of K-ras mutations in colorectal cancer tissue is associated with a lack of response to treatment with Vectibix in patients with colorectal cancer.  This test is used to aid doctors in selecting patients with advanced colorectal cancer for treatment with Vectibix.  If the test result indicates that a K-ras mutation is absent in the colorectal cells, then the patient may be considered for treatment with Vectibix.

How does it work?

  • The doctor takes a small amount of colorectal tumor tissue sample from the patient and examines it (biopsy).
  • The tissue is embedded in a block of paraffin wax and a thin slice is cut from the block for use in the test.
  • DNA is isolated from the patient’s tumor cells and is mixed with reagents that specifically detect, bind to, and make copies of a portion of the tumor’s K-ras gene.  This reaction produces fluorescence, which is then measured to determine the presence of the mutation in the tumor sample.
  • The presence of a mutation in the KRAS gene indicates that a patient with metastatic colorectal cancer is not likely to benefit with Vectibix treatment.

When is it used? To determine if a patient’s tumor characteristics suggest that they might be a candidate for Vectibix treatment.

What will it accomplish?  The therascreen KRAS RGQ PCR Kit helps to determine whether patients with metastatic colorectal cancer should be considered for treatment with Vectibix treatment, 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 online.

Page Last Updated: 01/11/2016
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