PIK3CA Five Mutations Detection Kit

Description:

AmoyDx^® PIK3CA Mutation Detection Kit is a real-time PCR assay for in vitro diagnostics (IVD). The kit allows for the qualitative detection of up to 11 somatic mutations in the PIK3CA gene, using human DNA extracted from solid tumor formalin-fixed paraffin-ded (FFPE) tissue samples. It is designed to assist in identifying the PIK3CA mutation status in patients who may qualify for approved targeted therapies. This kit is intended for in vitro diagnostic use and should be operated by trained professionals within a laboratory setting.

Principle:

The kit adopts Amplification Refractory Mutation System (ARMS) and real-time PCR technology, which comprises specific primers and fluorescent probes to detect PIK3CA mutations in human genomic DNA. During the nucleic acid amplification, the targeted mutant DNA is matched with the bases at 3’ end of the primer, amplified selectively and efficiently, then the mutant amplicon is detected by fluorescent probes labeled with FAM. While the wild-type DNA cannot be matched with specific primers, there is no amplification occurs.

High sensitivity: up to 1%
 

Detected mutations:

H1047R (CAT > CGT), H1047L (CAT > CTT), E542K (GAA >AAA), E545K (GAG> AAG), E545D (GAG > GAT), H1047Y (CAT>TAT), E545A (GAG>GCG), E545G (GAG>GGG), Q546R (CAG>CGG), Q546E (CAG>GAG), C420R (TGT>CGT)

Tests/kit: 24 (bulk)

Instrument: Stratagene Mx3000P™, ABI7500, LightCycler480 II, Bio-Rad CFX96, SLAN-96S