[Histonet] Dako EGFR Kit


The use of the DakoCytomation EGFR kit seems to be a hot topic currently,
and I'd like to have some feedback as to how to interpret the following
excerpt from the Erbitux package insert, obtained from the following link
through the FDA (see page 8 of this document)


The excerpt is as follows "Patients enrolled in the clinical studies were
required to have immunohistochemical evidence of positive EGFR expression
using the DakoCytomation EGFR PharmDx test kit.  Assessment for EGFR
expression should be performed by laboratories with demonstrated proficiency
in the specific technology being utilized.  Improper assay performance,
including use of suboptimally fixed tissue, failure to utilize specified
reagents, deviation from specific assay instructions, and failure to include
appropriate controls for assay validation, can lead to unreliable results.
Refer to the DakoCytomation test kit package insert for full instructions on
assay performance".

Is this to be interpreted that only the Dako EGFR PharmDx kit is to be used
for EGFR testing in patients who are to receive Erbitux, or can another EGFR
clone be used as long as it has been validated for optimal use within the
laboratory that is performing the testing?  Or, is it acceptable to use
another assay if it has been validated against the Dako EGFR Pharm Dx kit?


Patty Kubier
ProPath Immunohistochemistry

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