KRAS, NRAS, PIK3CA and BRAF genes are four important genes of the downstream EGFR dependent RAS-RAF-MAPK pathway and PI3K-AKT pathway, these genes lead to sustained activation of downstream signaling, causing abnormal cell proliferation and differentiation, and ultimately tumorigenesis. Mutations in the KRAS, NRAS, PIK3C4 and BRAF genes are common in multiple malignancies, with mutation rates in colorectal cancer patients being 20–50%,16%, 10–30% and 8 to 15% , respectively.

UltraDx KRAS/NRAS/PIK3CA/BRAF Mutations Detection Kit tested 1114 Chinese colorectal cancer patient samples, with a total mutation rate of 52.15% in the KRAS/NRAS/PIK3CA/BRAF gene. Clinical studies have found that KRAS/NRAS/PIK3CA/BRAF mutant colorectal cancer patients were treated with anti-EGFR antibodies, and the analysis of the mutation status of these four genes in colorectal cancer patients can help to improve the objective response rate of treatment.

UltraDx KRAS/NRAS/PIK3CA/BRAF Mutations Detection Kit does not conduct joint clinical trials with drugs, but only verifies the detection performance of KRAS/NRAS/PIK3CA/BRAF mutations in colorectal cancer patients. The test results are only for clinical reference, and should not be used as the solebasis for individualized treatment of patients. Clinicians should comprehensively judge the test results based on the patients’ condition, drug indications, treatment response and other laboratory testing indicators.

UltraDx KRAS/NRAS/PIK3CA/BRAF Mutations Detection Kit adopts Amplification Refractory Mutation System (ARMS) and real-time PCR technologies, which comprises specific primers and probes to detect KRAS, NRAS and BRAF mutations in human DNA samples. The KRAS, NRAS,PIK3CA and BRAF mutant sequences are amplified by the mutant-specific primers, and detected by the fluorescence-labeled probes.

UltraDx KRAS/NRAS/PIK3CA/BRAF Mutations Detection Kit includes a mutation detection system and an internal control system. The mutation detection system contains primers, FAM-labeled probes FAM-labeled probe and VIC-labeled probes specific for designated KRAS/NRAS/PIK3CA/BRAF mutations, which is used to detect the mutation status of KRAS, NRAS, PIK3CA and BRAF gene. The internal control system contains primers and ROX-labeled probe for a region of conserved segment in RAS gene, which is used to detect the presence of inhibitors and monitor the accuracy of the experimental operation.

The PCR amplification reaction system of this kit also contains the Uracil-N-Glycosylase and can selectively break the uracil glycosiside bond in the PCR fragment containing dU, effectively reducing false positives due to contamination of the PCR product.

• High sensitivity: Accurate detection of mutations as low as 1%.
• Strong Specificity: The specificity can be reached 99.5% by using PCR technology.
• Easy operation: results in 90 mins.
• Reliable: Internal and External controls are included.

Applicable sample type: FFPE tumor tissue

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Applied Biosystems™ Real time PCR system 7500, ABI QuantStudio™5 Real-time PCR system, LightCycler® 480 PCR system, Bio-Rad CFX96 real-time PCR instrument. Ultrassay eQ9600 Real Time qPCR System etc.