[Histonet] RE: Ventana's HER2 Dual ISH DNA Probe Cocktail

[Walter Benton]

In the past the FDA approval has been tied to running the antibody on the specific vendors' instrumentation using a predetermined protocol. This was true for Dako's EGFR that was FDA approved.

Ventana antibodies can be dispensed out of their vials and used on any instrumentation, however, you may have an IVD antibody at that point.

Definitely check around and see what others have to say.

Walter Benton HT(ASCP)QIHC
Histology Supervisor
Chesapeake Urology Associates
806 Landmark Drive, Suite 126
(All Deliveries to Suite 127)
Glen Burnie, MD 21061
443-471-5850 (Direct)
410-768-5961 (Lab)
410-768-5965 (Fax)
wbenton <@t> cua.md
________________________________________
From: histonet-bounces <@t> lists.utsouthwestern.edu [histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Bell, Lynne [Lynne.Bell <@t> cvmc.org]
Sent: Monday, June 20, 2011 1:28 PM
To: Histonet (histonet <@t> lists.utsouthwestern.edu)
Subject: [Histonet] Ventana's HER2 Dual ISH DNA Probe Cocktail

Ventana just received FDA approval for the first fully automated diagnostic assay for HER2 gene status determination in breast cancer patients.

I do not have a Ventana immunostainer and from what I have been told, it is a closed system and this new probe cocktail could not be used on another stainer, such as the Dako.

Is anyone out there in HistoLand using this new cocktail and am I correct that it would not work using the Dako Autostainer.

A Ventana rep may contact me with this information also.

Lynne Bell, HT (ASCP)
Histology Team Leader
Central Vermont Medical Center
Barre, Vermont  05641
802-371-4923


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