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Human PIK3CA Gene Mutation Assay Kit (Fluorescent PCR)

Specification: 

24 tests /kit.


Applicable instrument: Stratagene Mx3000P.


Product Description:

Adopting the ARMS-PCR method, this kit can be used to detect 5 hot-spot mutations in exons 9 and 20 of the PIK3CA gene (accounting for about 80-90% of PIK3CA mutations). Studies show that patients tend to benefit nothing from treatment with anti-EGFR and anti-HER2 in case of any PIK3CA mutation.  

This kit is used for qualitative assay of PIK3CA mutation(s) in patients with non-small cell lung cancer (NSCLC), colorectal cancer, and breast cancer. The product contains our proprietary stabilizer with which high specificity can be guaranteed and false positives can be avoided under the situation when the sensitivity reaches 1%.

The assay result can be used as the reference for clinicians’ selection of population who may receive iressa (gefitinib), tarceva (erlotinib), and conmana (icotinib) among NSCLC patients, population who may receive erbitux (cetuximab) and vectibix (panitumumab) among patients with colorectal cancer, and population who may receive herceptin (trastuzumab) among patients with breast cancer. The product can be used in in vitro tests only. The assay result can only be used for clinical reference and shall not be used as the only basis for diagnosis and treatment.


Product Features:

High selectivity——Detect as low as 1% of mutations in 5 ng/μl DNA from multiple types of samples

High sensitivity——Only a few hundred copies are needed to detect the target gene

High specificity——The amplification curve is flattening when wild type samples are tested

Easy to operate—— Pre-assembled to facilitate standard operation in the lab

Convenient and fast——Suitable for various PCR instruments, test completed in 90 minutes 

Stable and reliable——Closed tube reaction, IR-IC dual QC to avoid false negatives and positives

Convenient read-out——No non-specific amplification, read the result directly, no need to manually calculate the △CT value

Worry-free after-sales service——Instant response, comprehensive after-sales service   


Product Qualification:

This kit meets the requirements of the ISO13485 Quality Management System, and passed CE and NMPA certifications (GXZZ 20183401825). 


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