[Histonet] VENTANA ULTRA & ER,PR,HER2

[Kuhnla, Melissa]

Hi Antoinette,
We currently use Ventana's ER and PR on both XT and Ultra.  From what I
understand, the antibody dispenser is labeled IVD. We report all cases
as being 'approved by the FDA for IVD use'.  We do perform
correlation/precision studies twice a year. For this study we run five
cases on both the XT and an ultra and document that the result comes out
the same.  I have actually found that this is a compliance issue with
Joint Commission. I can try to find the reference if you need it. It
states that if you are running the same test on two different platforms,
you must prove correlation.

As far as the Her2 dual ISH, we are in the process of evaluating it now.
I see it as a definite advantage that it is bright field, permanent, and
has the potential to dramatically increase TAT. We are in the middle of
a cost analysis.  On the other hand, we currently run Pathvysion and I
see that some literature calls FISH and pathvysion the 'gold standard'.
This is the most highly scrutinized test we perform considering the
CAP/ASCO guidelines. My gut also tells me...why take a chance with this
when our current system is not 'broken'? I did find that CAP offers two
mailings for profiency testing using bright field ISH. 
Let me know how you make out. Hope this helps.
Melissa 

-----Original Message-----
From: histonet-bounces <@t> lists.utsouthwestern.edu
[mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of
Barbara.Crill <@t> LPNT.net
Sent: Tuesday, June 28, 2011 10:54 AM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] VENTANA ULTRA & ER,PR,HER2

We are investigating getting the Ventana Ultra.
I discovered that the ER, PR, & HER2 are not yet FDA approved.

If you are using the Ventana Ultra how are you doing the ER, PR, & HER2?
Do you use the Benchmark XT?

Is anyone using the INFORM HER2 Dual ISH DNA Probe Cocktail Assay?




ANTOINETTE CRILL,
E-mail:  barbara.crill <@t> LPNT.net<mailto:barbara.crill <@t> LPNT.net>

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