RE: [Histonet] FW: [IHCRG] Very important question!!!!!!!!!!!!!!! !

From:"Houston, Ronnie"

The clinical trials that gained FDA approval for Erbitux were based on
positivity with the DakoCytomation EGFR pharmDx kit. It gives some creedence
to the story that insurance companies will not pay for the drug unless this
specific kit is used; certainly in the embryonic status of the drug's usage.

It should be added though, that during the clinical trials no-one with a
negative result by IHC was included in the study. Oncologists are asking
whether there is a need to order the test. Perhaps those "negative" patients
will also beneficially respond to Erbitux. There is no evidence to suggest
they won't.


Ronnie Houston
Director of Anatomic Pathology
Bon Secours HealthPartners Laboratories
5801 Bremo Road
Richmond, VA 23226
(804) 287 7972
(804) 287 7906 - fax 

-----Original Message-----
From: []
Sent: Friday, March 05, 2004 3:06 PM
Subject: Re: [Histonet] FW: [IHCRG] Very important
question!!!!!!!!!!!!!!! !

I have heard this stuff before ie: herceptest,however i am very aware of the
hcfa form used in billing (it is universal-all over the country)and nowhere
does it ask what test method!!!! now i think it might be wise to run some
correlation studies with the dako kit, but the antibody egfr has been around
longer than erbitux and from many manufacturers, and all that said one has
to do whats best for ones lab and with the pathologists approval. i run a
different clone for her2 and i run cd117 for another monoclonal
therapy(gleevic) and all patients are receiving according to their doctors
whatever they need and were getting paid, and yes there is full disclosure
on our reports. just my 2 cents

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