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therascreen FGFR RGQ RT-PCR Kit

For qualitative detection of actionable alterations in the FGFR3 gene
  • The only FDA-approved FGFR alteration assay on the market
  • Detection of four point mutations and two fusions in the FGFR3 gene
  • High sensitivity and specificity
  • Simple workflow with next-day results
  • Automated data analysis using Rotor-Gene AssayManager v2.1 software
The therascreen FGFR RGQ RT-PCR Kit is a qualitative in vitro diagnostic test for the detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3:TACC3v1 and FGFR3:TACC3v3) in the FGFR3 gene.
The therascreen FGFR RGQ RT-PCR Kit is the only FDA-approved companion diagnostic (CDx) test for the identification of patients with cases of urothelial cancer (UC) that harbor these actionable FGFR alterations, and for whom treatment with BALVERSA (erdafitinib) is indicated.
Cat No./ID: 73604
RNeasy DSP FFPE Kit
$482.00
Order Product
For 50 RNA preps: RNeasy MinElute Spin Columns, Collection Tubes, Elution Tubes, Deparaffinization Solution, Proteinase K, RNase-Free DNase I, DNase Booster Buffer, RNase-Free Buffers and RNase-Free Water
Cat No./ID: 874721
therascreen FGFR RGQ RT-PCR Kit (24)

For 24 reactions: Reverse Transcriptase, RT Buffer 1, RT Buffer 2, RT Primer Mix, Mutations-1 Reaction Mix, Mutations-2 Reaction Mix, Fusions-1 Reaction Mix, Fusions-2 Reaction Mix, Water for NTC, Water for sample dil., FGFR Positive Control, PC Diluent

Cat No./ID: 9002035
Rotor-Gene Q MDx Platform (US)
Real-time PCR cycler with 6 channels (the red and HRM channels are not intended for use with FDA cleared or approved nucleic acid tests), laptop computer, software, accessories, 1-year warranty on parts and labor
Cat No./ID: 9002036
Rotor-Gene Q MDx System (US)
Real-time PCR cycler with 6 channels (the red and HRM channels are not intended for use with FDA cleared or approved nucleic acid tests), laptop computer, software, accessories, 1-year warranty on parts and labor, installation and training
Cat No./ID: 9024203-US
Rotor-Gene AssayManager v2.1
Software for routine testing in combination with Rotor-Gene Q MDx instruments.

IMPORTANT: Does not include license for use. License key must be purchased separately.

Visit the Download Page for download, installation and licensing instructions.

The therascreen FGFR RGQ RT-PCR Kit is intended for in vitro diagnostic use.


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In vitro diagnostic medical device.
Performance
Concordance between the clinical trial assay (CTA) used to identify patients for recruitment to the Phase 2 clinical trial of BALVERSA (42756493-BLC2001) and the therascreen FGFR RGQ RT-PCR Kit (CDx) was evaluated in a bridging study (1).

Samples with valid results for both therascreen FGFR RGQ RT-PCR Kit and CTA (279/287 patients; 97.2%) were analyzed to assess the positive percent agreement (PPA), negative percent agreement (NPA) and overall percent agreement (OPA), based on agreement between the two methods for overall FGFR gene alteration status (i.e., FGFR alteration detected or No FGFR alteration detected) Results are shown in Table 1.

Table 1 therascreen FGFR RGQ RT-PCR  Kit versus CTA (with CTA as reference method)
Measure of agreement Percent agreement % (N) Two-sided 95% CI 
Positive percent agreement (PPA) 85.2% (69/81) 75.9, 91.3 
Negative percent agreement (NPA)* 97.0% (192/198) 93.5, 98.6
Overall percent agreement (OPA)  93.5% (261/279) 90.0, 96.1
*Prior chemotherapy information was not collected for CTA-negative patients. Therefore, 198 CTA-negative subjects included both Chemo Relapsed/Refactory and Chemo Naïve patients.

The primary objective of the BLC2001 clinical trial was to evaluate the objective response rate (ORR) to treatment with BALVERSA in subjects with cases of UC in which FGFR alterations were detected. ORR was defined as complete response (CR) plus partial response (PR) by RECIST criteria, as assessed by blinded independent review committee (BIRC). The observed clinical benefit of treatment with BALVERSA in the subset of patients in which FGFR alterations were detected with both the therascreen FGFR RGQ RT-PCR Kit and the CTA (n = 69) was comparable to that observed in the full study population, as defined by the CTA only (n = 87). The ORR in patients in whom FGFR alterations were detected by both the therascreen FGFR RGQ RT-PCR Kit and the CTA, as assessed by BIRC, was 33.3% (95% CI: 23.4-45.1%).

The therascreen FGFR RGQ RT-PCR Kit is therefore indicated for use as an aid in identifying patients with cases of urothelial cancer which harbor these alterations and are therefore eligible for treatment with BALVERSA (erdafinitib).
Principle
The therascreen FGFR RGQ RT-PCR assay is based on the selective amplification of alterations in the FGFR genes using the Rotor-Gene Q MDx (US) instrument for sensitive and specific analysis. The assay exploits the qPCR oligonucleotide hydrolysis principle using TaqMan probes.

Allele-specific technology allows accurate and highly reproducible detection of alterations, based on the use of specific forward and reverse primers and probes; only a perfect match between the primers and probes with the target cDNA allows extension and amplification in the PCR reaction. Result reporting is fully automated. If both the run controls and the sample results are valid and sufficient assay target amplification occurs below the pre-determined cycle number cut-off threshold, the report will show the FGFR alteration(s) detected in each sample.
Procedure
The fast and simple workflow takes ~12 hours from Sample to Insight.

RNA is first prepared from formalin-fixed paraffin-embedded (FFPE) urothelial tumor samples using the RNeasy DSP FFPE Kit. Purified RNA is then reverse transcribed using Reverse Transcriptase to generate cDNA for real-time PCR analysis. Optimized ready-to-use reverse transcription reagents and PCR master mixes provided in the kit enable high-fidelity reverse transcription and sensitive real-time PCR on the Rotor-Gene Q MDx (US) instrument. Qualitative results are displayed in Rotor-Gene AssayManager software, informing the system operator if one or more of the four point mutations and two fusions in the FGFR3 gene detected by the kit are present.

The therascreen FGFR RGQ RT-PCR kit is also designed to identify FGFR2 fusions FGFR2:BICC1 and FGFR2:CASP7 and FGFR3 fusion FGFR3:BAIAP2L1, because patients harboring these FGFR fusions were eligible for the BLC2001 clinical trial. However, the test is not clinically validated to detect these three fusions. Drug safety and efficacy has not been established for cases of UC harboring these fusions and no claims are made for the use of the therascreen FGFR RGQ RT-PCR kit as an aid in the selection of such patients for treatment with BALVERSA (erdafitinib).
Applications
The therascreen FGFR RGQ RT-PCR Kit enables qualitative detection of four point mutations and two fusions of the FGFR3 gene for in vitro diagnostic use. It is the only FDA-approved CDx assay for the selection of patients with cases of urothelial cancer (UC) harboring actionable alterations, for whom treatment with BALVERSA (erdafitinib) is indicated.

1. Janssen Biotech, Inc. Data on file.

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Instrument User Manuals (4)
For use with Rotor-Gene Q Software version 2.3.4
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For use with Rotor-Gene Q Software version 2.3.4
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For use with Rotor-Gene AssayManager v2.1 Gamma MDx (US) Plug-in
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Operating Software (4)
For use on the Rotor-Gene Q. Rotor-Gene Q Software 2.3.4 is compatible with both Windows 10 and Windows 7 operating systems.
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Gamma MDx Plug-in for use with Rotor-Gene AssayManager v2.1 MDx (US)
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To download Rotor-Gene AssayManager v2.1 after purchase:
    Click the "Download" button and follow the on-screen instructions to install Rotor-Gene AssayManager v2.1.
    Rotor-Gene AssayManager v2.1 and license must be purchased prior to use.    

    IMPORTANT: In order to perform and analyze runs, at least one Rotor-Gene AssayManager v2.1 plug-in needs to be installed. Refer to your assay kit handbook for more information.

To purchase a license key for Rotor-Gene AssayManager v2.1:
    1. After purchasing Rotor-Gene AssayManager v2.1 software and licenses, click the "Download" button and follow the onscreen instructions to install. After successful installation of the Rotor-Gene AssayManager v2.1 and a plug-in, a “key file” will be generated. This "key file" will be attached to the "Technical Support Form" in Step 5, below.   
    2. Go to the Technical Support Form. Make sure to include all required information and your Rotor-Gene Q or Rotor-Gene Q MDx serial number when filling out the form.       
    3. For Question 2, "Type of Request", select “Other”.
    4. For Question 4, “Your inquiry”, enter "Rotor-Gene AssayManager license request” and include your purchase order number, from your order confirmation.
    5. Include the "key file" from Step 1 as an attachment.
    6. Submit the form. QIAGEN Technical Services will respond via email with a license file within 1–2 working days.    
    7. After receiving your computer-specific Rotor-Gene AssayManager v2.1 license file, archive the license file locally on your computer.

IMPORTANT: The license file must always exist on the computer that has Rotor-Gene AssayManager v2.1 installed. The license file location should be protected and not subject to change.


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