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Oncology & Haematology
TruPCR Distributed by Goffin Diagnostics

EGFR Real-time PCR Kit

The TruPCR EGFR Mutation Kit detects 32 mutations across exons 18, 19, 20 and 21 of the EGFR gene by allele-specific ARMS real-time PCR, with a stated sensitivity of 1 per cent mutant DNA. The panel includes the exon 19 deletions, p.L858R and the resistance mutation p.T790M. In non-small cell lung cancer these results determine the choice of tyrosine kinase inhibitor. DNA from fresh, frozen or formalin-fixed paraffin-embedded tissue is used.

Real-Time PCR CE-IVD TruPCR 1 Unit (48 Reactions)
Technique
Real-Time PCR
Brand
TruPCR
Packaging
1 Unit (48 Reactions)
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Product details

This kit in detail

  • 32 EGFR mutations across exons 18, 19, 20 and 21
  • Includes the exon 19 deletions, p.L858R and p.T790M
  • ARMS PCR with selective amplification of the mutant allele
  • Sensitivity 1 per cent mutant DNA
  • Internal extraction control against false negatives
  • 24 or 48 reactions per kit, REF 3B1311 and 3B1312

The TruPCR EGFR Mutation Kit determines the EGFR mutation status of a lung tumour, the result that decides whether a tyrosine kinase inhibitor is an option and which generation of inhibitor applies.

Clinical background

EGFR is a receptor tyrosine kinase that regulates cell growth and survival. In non-small cell lung cancer, activating mutations keep the receptor switched on: the deletions in exon 19 and p.L858R in exon 21 account for most of them and predict a response to tyrosine kinase inhibitors. p.T790M in exon 20 is the resistance mutation that appears under treatment with a first or second generation inhibitor, and it dictates the switch to a third generation drug.

Method and sensitivity

The assay uses ARMS PCR, in which the primer amplifies only the mutant allele, so a small mutant fraction can be detected against a wild-type background. The stated sensitivity is 1 per cent. An internal extraction control is amplified alongside, so a negative result can be distinguished from a failed extraction. DNA from fresh, frozen or formalin-fixed paraffin-embedded tumour tissue is used.

Documentation

Datasheets and regulatory documentation

Everything your quality team needs for evaluation and procurement.

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