K-RAS

Primary DI

06975977070100

Basic UDI-DI Code

B-06975977070100

Reference

600010

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Gold Probe Diagnostic Biotechnology Inc. MF

PRODUCT NAME KRAS/NRAS/PIK3CA/BRAF Mutations Detection Kit（Real-time PCR Assays），KRAS, NRAS, PIK3CA and BRAF genes are four importantgenes of the downstream EGFR dependent RAS-RAF-MAPKpathway and PI3K-AKT pathway, these genes lead to sustainedactivation of downstream signaling, causing abnormal cellproliferation and differentiation, and ultimately tumorigenesis. Mutations in the KRAS, NRAS, PIK3C4 and BRAF genes arecommon in multiple malignancies, with mutation rates incolorectal cancer patients being 20–50%,16%, 10–30% and 8 to15% , respectively. This 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 withanti-EGFR antibodies, and the analysis of the mutation status ofthese four genes in colorectal cancer patients can help toimprove the objective response rate of treatment. This kit does not conduct joint clinical trials with drugs, but onlyverifies the detection performance of KRAS/NRAS/PIK3CA/BRAFmutations in colorectal cancer patients. The test results are onlyfor clinical reference, and should not be used as the solebasis for individualized treatment of patients. Clinicians should comprehensively judge the test results based on thepatients' condition, drug indications, treatment response andother laboratory testing indicators.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).