EGFR 29 Mutations Detection Kit

Description:

The AmoyDx^® EGFR 29 Mutations Detection Kit is a real-time PCR assay. This kit enables qualitative detection of up to 29 somatic mutations in exons 18-21 of the EGFR gene in human genomic DNA extracted from formalin-fixed paraffin-ded (FFPE) tumor tissue or circulating DNA extracted from plasma/serum. It is intended to aid in identifying EGFR mutation status for patients with non-small cell lung cancer (NSCLC) who may be eligible for approved targeted therapies. The kit is for in vitro diagnostic use and intended to be used by trained professionals in a laboratory environment.

Principle:

The kit adopts Amplification Refractory Mutation System (ARMS) and real-time PCR technology, which comprises specific primers and fluorescent probes to detect EGFR 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:

• Exon 18: G719A, G719C, G719S

• Exon 19: 19 deletions

• Exon 20: T790M, S768I, 3 insertions

• Exon 21: L858R, L861Q

Tests/kit: 24 (bulk)

Instrument: Stratagene Mx3000P™, ABI 7300, ABI 7500, ABI 7900HT, ABI StepOnePlus, LightCycler480 II, cobas^® z480, Bio-Rad CFX96, SLAN-96S