[Histonet] VENTANA ULTRA & ER,PR,HER2

[Mark Tarango]

I think Barbara was referring to the approval for the ER, PR and Her2
antibodies being for use with the Benchmark XT stainers and that they aren't
yet approved for use on the ULTRA stainers using newer formulated bulk
reagents.  It's funny because they both use the same detection kits and
antibodies.  The formulation for the bulk reagents is different and it is a
new instrument, so I think that's why they need another approval from the
FDA.   The antibodies were already approved for use with the Benchmark XT
stainers.

We aren't running Ventana's new Dual ISH Her2 probe kit but we will be
looking at it.  It does seem to have some perks from the lab's point of
view.  The instrument does the entire ISH procedure/stain.  No more having
to mix the reagents for the pretreatment as with Abbott's Pathvysion Kit,
repeated pipetting, 22 x 22 coverslips or rubber cement.  It's even worse if
you don't have a VP2000 pretreatment unit, then you're stuck doing FISH
pretreatment by hand with coplin jars in waterbaths.   You don't need a
fluorescent scope to see the slide with Ventana's new kit and it would be
easy for the pathologist to make sure the correct area is scored for Her2
amplification (as can be a problem with the pathologist circling the area of
interest on an H&E and the tech matching it up to another unstained serial
section with Her2 FISH).  I know a lot of labs use the Pathvysion kit "off
label" and dilute the probe and change other things from the original FDA
approved protocol.  Then again, even deparaffinzing the slide using xylene
is "off label", since it was approved using Hemo-D substitute.  I imagine it
would be harder to go "off label" with Ventana's software.   I guess you've
got to weigh the pros and cons as with everything.

Mark Tarango

On Sun, Jul 3, 2011 at 2:28 AM, Gudrun Lang <gu.lang <@t> gmx.at> wrote:

> The Her2 CB11 clone of Ventana is FDA approved. In the package insert of
> the
> Her2 4B5 clone is stated, that the antibody was compared to CB11 and shows
> same or better performance.
> The CB11 clone was exchanged through 4B5.
>
> On the NordiQC website Ventana 4B5 and Dako Herceptest are called FDA
> approved.
> http://www.nordiqc.org/Run-30-B10/Assessment/assessment-B10-HER2.htm
>
> So in my opinion the company wouldn't exchange its antibody, if it wouldn't
> be approved now or soon.
>
> Gudrun Lang
>
>
>
> -----Ursprüngliche Nachricht-----
> Von: histonet-bounces <@t> lists.utsouthwestern.edu
> [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] Im Auftrag von Patsy
> Ruegg
> Gesendet: Samstag, 02. Juli 2011 18:09
> An: Barbara.Crill <@t> LPNT.net; histonet <@t> lists.utsouthwestern.edu
> Betreff: RE: [Histonet] VENTANA ULTRA & ER,PR,HER2
>
> I thought Ventana and Dako both had FDA approved Her2, I know Dako has
> Hercept Test.
>
> Patsy Ruegg, HT(ASCP)QIHC
> IHCtech
> 12635 Montview Blvd. Ste.215
> Aurora, CO 80045
> 720-859-4060
> fax 720-859-4110
> www.ihctech.net
> www.ihcrg.org
>
> -----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 8:54 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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