RE: [Histonet] Dako EGFR Kit

From:"Poteete, Jacquie A."

Patty, our research people and Medical Oncologists will not accept our
"other EGFR".  When we did our verification, we had several specimens that
tested positive with our other DAKO clone and did not test positive with the
test kit clone.  Most of the protocols we work with are extremely specific
in regards to both the EGFRdx and Her-2 test KITS.

Jacquie Poteete MT(ASCP)QIHC
Lead Technologist, IHC Laboratory
Saint Francis Hospital, Tulsa, OK

> -----Original Message-----
> From: []
> Sent:	Friday, March 05, 2004 4:52 PM
> To:
> Subject:	[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
> 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?
> Thanks,
> Patty Kubier
> ProPath Immunohistochemistry
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