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FGFR RGQ RT-PCR

Test Code

M FGFR

Test Synonyms

The therascreen® FGFR RGQ RT-PCR test

Associations

Urothelial cancer, transitional carcinoma, bladder cancer

Methodology

QIAGEN FDA-approved therascreen® FGFR RGQ RT-PCR Kit (therascreen FGFR Kit)

Turnaround Time

7 days

Specimen Requirements

Formalin Fixed Paraffin Embedded tissue block
3 slides (3-5 uM) on adhesion glass
NOTE: Include a surgical pathology report with the sample if sending a block and/or slides

Specimen Stability
Indefinite at ambient temperature (18-25°C)
Storage & Handling

Ship ambient. Protect from extreme temperature with an ice pack. Separate ice pack from specimen

Causes for Rejection

• Improper specimen labeling
• Incorrect specimen type (other than FFPE tissue)
• Absence of tissue or insufficient tumor tissue in the block or slides after pathologist H&E review

Description

The therascreen® FGFR RGQ RT-PCR test (therascreen FGFR Kit) is used as a companion diagnostic to help guide the use of the newly FDA-approved FGFR kinase inhibitor, BALVERSA™ (erdafitinib), developed by Janssen Biotech, Inc (BALVERSA Press Release). This test will aid in identifying patients with urothelial cancer whose tumors have specific alterations in the fibroblast growth factor receptor 3 (FGFR3) gene or FGFR fusions. The U.S. Food and Drug Administration co-approved the therascreen® FGFR RGQ RT-PCR test with the BALVERSA™  drug (BALVERSA Press Release) specifically for testing urothelial cancer (UC) specimens preserved in FFPE.

Urothelial carcinoma (UC), also known as transitional carcinoma, is the most common form of bladder cancer.  Of the ~ 80,000 new cases of bladder cancer per year, about 20% of the patients have muscle-invasive or metastatic disease (Dietrich & Srinivas, 2018).  Across all UC, ~20% of specimens contain activating FGFR3 alterations or FGFR fusions fulfilling candidacy requirements for treatment with BALVERSA™.  In clinical trials, patients treated with BALVERSA™ demonstrated a 32.2 % objective response rate (2.3% achieving a complete response and 29.9% achieving a partial response) (BALVERSA Prescribing Information).

References