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® FGFR RGQ PCR Kit
PMA Applicant: QIAGEN Manchester Ltd
Address: Skelton House, Lloyd Street North, Manchester M15 6SH United Kingdom
Approval Date: April 12, 2019
Approval Letter: Approval Order
What is it?
The therascreen® fibroblast growth factor receptor (FGFR) Rotor-Gene Q (RGQ) polymerase chain reactions (PCR) kit tests a tumor sample from patients with urothelial cancer for genetic mutations in certain fibroblast growth factor receptor (FGFR2 and FGFR3) genes. These genetic mutations may cause cancer to grow.
When is it used?
Doctors use the therascreen® FGFR RGQ PCR kit laboratory test to select the best treatment options for a patient with urothelial cancer, including determining whether Balversa™ (erdafitinib), a drug that slows the growth of tumors that have certain mutated FGFR genes, is a treatment option.
How does it work?
The doctor takes a small amount of tumor tissue from the patient’s tumor and sends it to a lab. At the lab, ribonucleic acid (RNA) is isolated from the patient’s tumor cells and mixed with reagents that specifically make copies of the tumor’s FGFR genes. Different colored dyes are used to detect normal FGFR genes and mutant FGFR genes. The lab results are reported to the patient’s doctor, who then uses this information to help select the best treatment options for their urothelial cancer patients, including determining whether Balversa™ (erdafitinib) is a treatment option.
What will it accomplish?
The therascreen® FGFR RGQ PCR Kit helps to determine whether patients with urothelial cancer should be considered for treatment with Balversa™ (erdafitinib), which may prolong their life.
When should it not be used?
The test should only be used on patients with urothelial cancer. There are no known contraindications.