therascreen BRAF V600E RGQ PCR Kit

For qualitative detection of V600E mutations in the BRAF gene using real-time PCR


The therascreen BRAF V600E RGQ PCR Kit is intended for in vitro diagnostic use.
therascreen BRAF V600E RGQ PCR Kit (24)

Cat. No. / ID:  874854

For 24 reactions: Control Reaction Mix, V600E Reaction Mix, BRAF Positive Control, Taq DNA Polymerase, Water for NTC, Water for Dilution
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Rotor-Gene Q MDx 5plex HRM

Cat. No. / ID:  900706

Real-time PCR cycler and High Resolution Melt analyzer with 5 channels (green, yellow, orange, red, crimson) plus HRM channel, laptop computer, software, accessories, 1-year warranty on parts and labor
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QIAamp DNA FFPE Tissue Kit (50)

Cat. No. / ID:  56404

For 50 DNA preps: 50 QIAamp MinElute Columns, Proteinase K, Buffers, Collection Tubes (2 ml) Use our next-generation QIAamp DNA FFPE Advanced Kits for improved performance.
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Rotor-Gene AssayManager v2.1

Cat. No. / ID:  9024203

Software for routine testing in combination with Rotor-Gene Q and 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.
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For up-to-date licensing information or Rotor-Gene Q instrument specific disclaimers, refer to the corresponding Rotor-Gene Q instrument user manual
Rotor-Gene AssayManager v2.1 License (1)

Cat. No. / ID:  9025620

Single license for the installation of Rotor-Gene AssayManager v2.1 software on one computer. For installation on multiple computers, each computer requires an individual computer-specific license key.Visit the Download Page for software download, installation and licensing instructions.
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  • PMDA-approved BRAF mutation companion diagnostic test
  • Reliable detection of V600E mutations in the BRAF gene
  • High sensitivity and specificity
  • Simple workflow from sample to insight
  • Automated data analysis using Rotor-Gene AssayManager for fast, easy result determination

Product Details

The therascreen BRAF V600E RGQ PCR Kit is a qualitative in vitro diagnostic test for the detection of V600E mutations in the BRAF gene. The test analyzes DNA extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue, taken from a patient with colorectal cancer (CRC). It is intended to aid clinicians in identifying metastatic colorectal cancer (mCRC) patients eligible for treatment with either a triplet therapeutic regime of BRAFTOVI (encorafenib) plus MEKTOVI (binimetinib) plus cetuximab (genetic recombinant), or a doublet therapeutic regime of BRAFTOVI (encorafenib) plus cetuximab (genetic recombinant).


The clinical performance of the kit was determined in the BEACON CRC Study. This was a three-arm, multicenter, randomized, open-label, Phase 3 study of encorafenib + cetuximab (genetic recombinant) plus (triplet arm) or minus (doublet arm) binimetinib versus irinotecan/cetuximab (genetic recombinant) or infusional 5-fluorouracil/folinic acid/irinotecan/cetuximab (genetic recombinant) (control arm) in patients with BRAF V600E mutant metastatic CRC.

The study comprised 665 patients (224 triplet arm; 220 doublet arm; 221 control arm). Study endpoints included overall survival (OS) and overall response rate (ORR) by BICR (Blinded Independent Central Review) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

The study demonstrated a statistically significant clinical improvement in OS and confirmed ORR by BICR for both the triplet and the doublet arm versus the control arm, with a 48% (triplet) and 40% (doublet) reduction in risk of death observed compared to the control arm (triplet: HR 0.52, 95% CI: 0.39, 0.70; doublet: HR 0.60, 95% CI: 0.45, 0.79).

Therefore, there is a clear clinical benefit to determining BRAF mutation status when determining patient eligibility for treatment with either encorafenib + cetuximab (genetic recombinant) + binimetinib or encorafenib + cetuximab (genetic recombinant).


The therascreen BRAF V600E RGQ PCR Kit is comprised of one mutation and one control reaction mix utilized to detect the V600E mutation in the BRAF gene. Allele-specific technology allows accurate and highly reproducible detection of mutations; DNA is selectively amplified using ARMS primers and Scorpions probes, with sensitive signal detection using the Rotor-Gene Q MDx instrument. Result reporting is fully automated. If both the run controls and the sample results are valid and target assay amplification is below the preset cutoff, the report will show the V600E mutation as detected in the sample.


The simple and easy testing workflow begins with manual DNA extraction from mCRC tumor tissue using the QIAamp DNA FFPE Tissue Kit, followed by sensitive real-time PCR on the Rotor-Gene Q MDx instrument. Rotor-Gene AssayManager software rapidly and accurately determines mutations and reports results, informing the system operator if the V600E mutation is present in the sample.


The therascreen BRAF V600E RGQ PCR Kit enables qualitative detection of V600E mutations in the BRAF gene for in vitro diagnostic use. It is an PMDA-approved companion diagnostic assay to identify patients with cases of metastatic colorectal cancer for whom treatment with BRAFTOVI (encorafenib) plus MEKTOVI (binimetinib) plus cetuximab (genetic recombinant), or BRAFTOVI (encorafenib) plus cetuximab (genetic recombinant) may be appropriate.


Brochures & Guides (6)
High-quality, nucleic acid purification for successful PCR and NGS experiments.
Second edition — innovative tools
Sample to Insight solutions for successful molecular analysis
Critical factors for molecular analysis of FFPE samples
FFPE サンプルの分子解析における重要なファクター
Operating Software (3)
For use on the Rotor-Gene Q. Rotor-Gene Q software 2.3.5 is compatible with Windows 7 and Windows 10 operating systems
Gamma Plug-in for use with Rotor-Gene AssayManager v2.1
To download Rotor-Gene AssayManager v2.1.1 after purchase:
    Click the Rotor-Gene AssayManager v2.1.1 Software header. On the next window, click Continue. Follow the on-screen instructions to install Rotor-Gene AssayManager v2.1.1.
    Rotor-Gene AssayManager v2.1.1 and license must be purchased prior to use.    

    IMPORTANT: In order to perform and analyze runs, at least one Rotor-Gene AssayManager v2.1.1 plug-in needs to be installed. Refer to your assay kit handbook for more information.

    IMPORTANT: To allow checksum integrity verification, use the value D24F10DEB7A1D60EE381E2AEA8789117D0980FCC.

To purchase a license key for Rotor-Gene AssayManager v2.1.1:
    1. After purchasing Rotor-Gene AssayManager v2.1.1 software and licenses, click the "Download" button and follow the onscreen instructions to install. After successful installation of the Rotor-Gene AssayManager v2.1.1 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 v2.1.1 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 v2.1.1 installed. The license file location should be protected and not subject to change.

Additional Resources (1)
Software User Guides (1)
For use with Rotor-Gene AssayManager v2.1 Gamma Plug-in
Instrument User Manuals (2)
For installation and setup of Rotor-Gene AssayManager v2.1
For use with Rotor-Gene AssayManager v2.1 Software
Protocol Files (1)
Certificates of Analysis (1)


I received a kit containing the MinElute columns; however, they were left out for a while and not stored at 2–8°C upon receipt. Can I still use them?

The MinElute spin columns included in the following kits should be stored at 2–8°C upon arrival: AllPrep DNA/RNA Micro, EpiTect Fast DNA Bisulfite, EpiTect Fast FFPE Bisulfite, EpiTect Fast LyseAll Bisulfite, EpiTect Plus DNA Bisulfite, EpiTect Plus FFPE Bisulfite, EpiTect Plus LyseAll Bisulfite, exoRNeasy Serum/plasma Maxi, exoRNeasy Serum/Plasma Midi, GeneRead DNA FFPE, GeneRead rRNA Depletion, GeneRead Size Selection, MinElute Gel Extraction, MinElute PCR Purification, MinElute Reaction Cleanup, miRNeasy FFPE, miRNeasy Micro, miRNeasy Serum/Plasma, QIAamp DNA FFPE, QIAamp DNA Investigator, QIAamp DNA Micro, QIAamp MinElute Media, QIAamp MinElute Virus Spin, QIAamp MinElute Virus Vacuum, RNeasy FFPE, RNeasy Micro, RNeasy Plus Micro.

Short-term storage (up to 4 weeks) at room temperature (15–25°C) does not affect the performance. However, for optimal performance and quality, storage temperature should not exceed 25°C.

FAQ ID - 3560
What is the composition of elution buffer ATE in the QIAamp DNA Investigator kit, QIAamp DNA FFPE Tissue kit and the QIAamp Fast DNA Stool Mini kit?

The composition of Buffer ATE is:

- 10 mM Tris-Cl pH 8.3

- 0.1 mM EDTA

- 0.04% NaN3 (sodium-azide)

FAQ ID -3122
What can be used as an alternative to the A260 measurement for quantification of small amounts of RNA and DNA?

Small amounts of RNA and DNA may be difficult to measure spectrophotometrically. Fluorometric measurements, or quantitative RT-PCR and PCR are more sensitive and accurate methods to quantify low amounts of RNA or DNA.

Fluorometric measurements are carried out using nucleic acid binding dyes, such as RiboGreen® RNA Quantitation Reagent for RNA, and PicoGreen® DNA Quantitation Reagent for DNA (Molecular Probes, Inc.).

FAQ ID -728