I believe all the experts are at NSH, but if I understand correctly, the FDA
has only approved the DAKO method for testing at this time. For patients to
be treated with Herceptin, this kit must have been used for testing their
tissue. I don't understand the response either!!!
Joyce Weems
Pathology Manager
Saint Joseph's Hospital of Atlanta


	-----Original Message-----
	From:	Wilson, Denise [SMTP:DWilson@brookdale.edu]
	Sent:	Tuesday, September 19, 2000 1:46 PM
	To:	'histonet@pathology.swmed.edu'
	Subject:	FW: ventana nexes - her2neu

	I am more confused than ever by this answer!



	> I am writing to clear up some confusion that exists regarding the
	> regulatory
	> status of one of our products, Ventana c-erbB-2 Primary Antibody,
Clone
	> CB11.  Currently this product is marketed as an Analyte Specific
Reagent.
	> It is, however, submitted to the FDA for review to obtain IVD
labeling.  
	> 
	> The type of submission filed with the FDA was a Premarket
Approval, or
	> PMA.
	> This is due to the fact that the FDA has classified this product
as a
	> Class
	> III Device.  Under 21CFR 864.1860 we are required by law to submit
a PMA
	> and
	> have it approved prior to marketing this product as an IVD test.
The FDA
	> will not accept a 510(k) submission for immunohistochemical assays
for
	> Her-2/neu.  Neither Ventana nor any other company may submit a
510(k). 
	> 
	> Hope this clears up any misinformation.
	> Regards!
	> 
	> BJ Kerns 
	> Director of Worldwide Strategic Marketing
	> Advanced Staining Reagents
	> 3865 N Business Center Drive
	> Tucson, AZ 85705
	> 1-800-227-2155 ext. 3577
	> 
	> -----Original Message-----
	> From: Wilson, Denise [mailto:DWilson@brookdale.edu]
	> Sent: Tuesday, September 19, 2000 9:33 AM
	> To: 'histonet@pathology.swmed.edu'
	> Subject: ventana nexes - her2neu
	> 
	> 
	> 
	> >  I am considering getting the Ventana Nexes for immuno but
recently came
	> > accross some disturbing information. I was told that the her2Neu
from
	> > ventana was not FDA approved, and that a doctor cannot prescribe
	> treatment
	> > based on this result. Does anyone out there know anything about
this?
	> > Please enlighten me on this subject, and while you are at it,
pros and
	> > cons of the nexes and Dako machines.	
	> > > Thanks	
	> > > Denise Wilson	
	> > > Brookdale Hospital
	> > > 
	> > 
	>