therascreen KRAS RGQ PCR Kit

For qualitative detection of the G12C mutation in the KRAS oncogene using real-time PCR

S_1179_2_CG_therascreen_KRAS_RGQ_PCR_Kit

✓ 24/7 automatic processing of online orders

✓ Knowledgeable and professional Product & Technical Support

✓ Fast and reliable (re)-ordering

therascreen KRAS RGQ PCR Kit (24)

Cat. No. / ID:  874052

For 24 reactions: 1 Control Assay, 7 Mutation Assays, Positive Control, Water, Taq DNA Polymerase
KitProduct
therascreen KRAS RGQ PCR (24) kit
QIAamp DNA FFPE Tissue Kit (50)
Rotor-Gene Q MDx 5plex HRM
The therascreen KRAS RGQ PCR Kit is intended for in vitro diagnostic use
The therascreen KRAS RGQ PCR Kit is intended for in vitro diagnostic use.

✓ 24/7 automatic processing of online orders

✓ Knowledgeable and professional Product & Technical Support

✓ Fast and reliable (re)-ordering

Features

  • PMDA-approved CDx for LUMAKRAS in NSCLC
  • Reliable detection of the KRAS G12C mutation
  • Ready-to-use system with simple workflow and next-day results
  • Automated data analysis using Rotor-Gene Q software

Product Details

The therascreen KRAS RGQ PCR Kit is a real-time, qualitative in vitro diagnostic test for the detection of the G12C somatic mutation in the KRAS oncogene using a sample of DNA extracted from formalin-fixed, paraffin-embedded (FPPE) non-small cell lung cancer (NSCLC) tissue.

The therascreen KRAS RGQ PCR Kit is a PMDA-approved companion diagnostic (CDx) PCR test intended to aid in the identification of NSCLC patients for treatment with LUMAKRAS (sotorasib) based on a KRAS G12C Mutation Detected result.

Performance

A clinical performance study demonstrated the clinical validity of the therascreen KRAS RGQ PCR Kit as a CDx test to aid the identification of NSCLC patients for treatment with LUMAKRAS (sotorasib). The objective of the study was to assess whether G12C mutation status, as determined by the therascreen KRAS RGQ PCR Kit, can be used to select patients with advanced NSCLC that will benefit from LUMAKRAS (sotorasib) treatment. Clinical trial 20170543 is an ongoing open-label, multicenter, phase 1/2 study designed to evaluate the efficacy and safety of LUMAKRAS (sotorasib) in adult subjects with advanced solid tumors that harbor the KRAS G12C mutation. Data from the primary analysis of the NSCLC phase 2 portion of this study has been used to support the clinical validity of the therascreen KRAS RGQ PCR Kit as a CDx test. Enrollment was restricted to subjects with KRAS G12C-mutated NSCLC as assessed by a local laboratory result, which was confirmed by central testing using the therascreen KRAS RGQ PCR Kit.

The primary endpoint of the NSCLC phase 2 portion of this study was to evaluate tumor objective response rate (ORR) assessed by RECIST 1.1 criteria of LUMAKRAS (sotorasib) as monotherapy in subjects with KRAS G12C-mutated advanced tumors.

Analysis was performed on 123 patients. The primary endpoint of ORR (complete response + partial response) was assessed by blinded independent centralized review (BICR) using RECIST 1.1. For subjects with KRAS G12C-mutated NSCLC ORR was 37.4% (46 of 123 subjects; 95% CI: 28.8-46.6%); 1.6% (two subjects) achieved complete response and 35.8% (44 subjects) achieved partial response.

Principle

The therascreen KRAS RGQ PCR Kit utilizes specific PCR reaction mixes and a wild‑type control. The mutation-specific reaction mix uses an amplification refractory mutation system (ARMS) primer to selectively amplify mutated DNA and then a Scorpions primer to detect the amplification product. If both the run controls and the sample results are valid, the therascreen KRAS RGQ PCR Kit qualitatively determines the mutation status of the DNA samples and reports if the sample contains the G12C mutation.

Procedure

The simple and straightforward testing workflow begins with manual DNA extraction from FFPE NSCLC tumor tissue using the QIAamp DNA FFPE Tissue Kit, followed by sensitive real-time PCR on the Rotor-Gene Q MDx 5plex HRM instrument. Rotor-Gene Q software rapidly and accurately determines mutations and reports results, informing the system operator if the KRAS G12C mutation is present. The assay can be completed in ~8 hours, providing next-day results.

Applications

The therascreen KRAS RGQ PCR Kit enables qualitative detection of the G12C mutation in codon 12 of the human KRAS gene for in vitro diagnostic use. The kit is intended to discriminate between KRAS G12C mutation-negative (wild-type) and KRAS G12C mutant tumors.

Supporting data and figures

Resources

Brochures & Guides (6)
Sample to Insight solutions for successful molecular analysis
High-quality, nucleic acid purification for successful PCR and NGS experiments.
Second edition — innovative tools
FFPE サンプルの分子解析における重要なファクター
Critical factors for molecular analysis of FFPE samples
Additional Resources (1)
Safety Data Sheets (1)
Protocol Files (1)
Version 3.1.1
Operating Software (1)
For use on the Rotor-Gene Q. Rotor-Gene Q software 2.3.5 is compatible with Windows 7 and Windows 10 operating systems
Certificates of Analysis (1)

FAQ

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