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  1. Recently-Approved Devices

The therascreen® BRAF V600E RGQ PCR Kit - P190026

The therascreen® BRAF V600E RGQ PCR Kit - P190026

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® BRAF V600E RGQ PCR Kit
PMA Applicant:  QIAGEN GmbH
Address:  QIAGEN Strasse 1 40724 Hilden, Germany
Approval Date:  April 15, 2020
Approval Letter:  Approval Order 

What is it? The therascreen® BRAF V600E RGQ PCR Kit is a laboratory test doctors use to detect the V600E mutation in the BRAF gene in tumor tissue from patients with metastatic colorectal cancer. Identifying these mutations will help patients with metastatic colorectal cancer get personalized treatments that target these genetic changes.

BRAFTOVI® (encorafenib) in combination with cetuximab are drugs used to treat patients with metastatic colorectal cancer.  The presence of BRAF V600E mutations in patients with metastatic colorectal cancer is associated with a response to treatment with BRAFTOVI® (encorafenib) in combination with cetuximab.  The therascreen® BRAF V600E RGQ PCR Kit helps doctors identify patients with metastatic colorectal cancer who should be treated with BRAFTOVI® (encorafenib) + cetuximab.

How does it work?  The doctor takes a small amount of cancer tissue from a patient’s tumor and sends it to a laboratory.  In the laboratory, DNA is isolated from the patient’s tumor cells and mixed with chemical substances (reagents) to evaluate the presence or absence of the BRAF V600E mutation.  A trained medical professional reviews the test results and sends the report to the ordering doctor.  The presence of the V600E mutation in the BRAF gene in the patient’s metastatic colorectal cancer tissue indicates the patient may be considered for treatment with BRAFTOVI® (encorafenib) + cetuximab. 

When is it used?  The therascreen® BRAF V600E RGQ PCR Kit is used to determine if a patient with metastatic colorectal cancer may be considered for treatment with BRAFTOVI® (encorafenib) + cetuximab.

What will it accomplish?  The therascreen® BRAF V600E RGQ PCR Kit helps to determine if a patient with metastatic colorectal cancer should be considered for treatment with BRAFTOVI® (encorafenib) + cetuximab.  

When should it not be used?  There are no known reasons not to use the test.

Additional information (including warnings, precautions and adverse events): 

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