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U.S. Department of Health and Human Services

Medical Devices

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therascreen® KRAS RGQ PCR Kit - P110030

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: July 6, 2012
Approval Letter:
http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110030a.pdf

What is it? The therascreen® KRAS RGQ PCR Kit is a genetic test 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 result in abnormal functioning of the protein.

This test is used to aid physicians in identifying patients with metastatic colorectal cancer for treatment with Erbitux®. Erbitux® (cetuximab) is a drug that may be used to treat patients with metastatic colorectal cancer.

The presence of K-ras mutations in colorectal cancer tissue indicates that the patient may not benefit from treatment with Erbitux®. If the test result indicates that the K-ras mutations are absent in the colorectal cancer cells, then the patient may be considered for treatment with Erbitux®.

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 a fluorescent light, which is then measured to determine the presence of the mutation in the tumor sample.
  • The presence of any of the seven mutations in the K-ras gene indicates that a patient with metastatic colorectal cancer is not likely to benefit with Erbitux® treatment.

When is it used? This test is used to determine if a patient’s tumor characteristics suggest that they might be a candidate for Erbitux® 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 Erbitux® 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.

Other Resources: