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

[Poteete, Jacquie A.]

In our study of the kit, we included several patients who had positive
results on the "old" EGFR.  Of the three, 2 were negative with EGFRdx and 1
was positive.  I'm certainly not brave enough to push my luck and accept the
liability for allowing my results to be the basis for entering patients on a
clinical trial or other treatment, based on results from the use of another
clone.  Our pathologists and oncologists refuse to accept anything other
than the FDA approved kits, but I also realize that this can vary from
institution to institution.  Some accept other clones or procedures, some
don't.

Jacquie Poteete MT(ASCP)QIHC
Lead Technologist, IHC Laboratory
Saint Francis Hospital, Tulsa, OK
japoteete <@t> saintfrancis.com

> -----Original Message-----
> From:	Houston, Ronnie [SMTP:Ronnie_Houston <@t> bshsi.com]
> Sent:	Friday, March 05, 2004 2:40 PM
> To:	'DDittus787 <@t> aol.com'; ploykasek <@t> phenopath.com;
> histonet <@t> pathology.swmed.edu
> Subject:	RE: [Histonet] FW: [IHCRG] Very important
> question!!!!!!!!!!!!!!! !
> 
> 
> 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
> 
> Ronnie Houston
> Director of Anatomic Pathology
> Bon Secours HealthPartners Laboratories
> 5801 Bremo Road
> Richmond, VA 23226
> (804) 287 7972
> (804) 287 7906 - fax
> ronnie_houston <@t> bshsi.com 
> 
> -----Original Message-----
> From: DDittus787 <@t> aol.com [mailto:DDittus787 <@t> aol.com]
> Sent: Friday, March 05, 2004 3:06 PM
> To: ploykasek <@t> phenopath.com; histonet <@t> pathology.swmed.edu
> 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
>                        dana
> 
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