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

[Houston, Ronald]

If you modify any part of the test protocol from the FDA approved methodology in any way, then it is no longer an FDA approved test.

Does that mean you cannot use it on your system? Absolutely not; you would have to validate it as you would any other antibody. 

However, you do need to be cognisant of the fact that if the FDA approved test is dependent on a patient going on a clinical trial or FDA approved treatment for a particular disease, your patient may not be accepted for that treatment regimen.

Ronnie Houston
Anatomic Pathology Manager
Nationwide Children's Hospital
Columbus OH 43205
(614) 722 5450

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Walter Benton
Sent: Monday, June 20, 2011 1:37 PM
To: Bell, Lynne; Histonet (histonet <@t> lists.utsouthwestern.edu)
Subject: [Histonet] RE: Ventana's HER2 Dual ISH DNA Probe Cocktail

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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