Re: [Histonet] VENTANA ULTRA ER,PR,HER2
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 HE 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.l...@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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] Im Auftrag von Patsy Ruegg Gesendet: Samstag, 02. Juli 2011 18:09 An: barbara.cr...@lpnt.net; histonet@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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of barbara.cr...@lpnt.net Sent: Tuesday, June 28, 2011 8:54 AM To: histonet@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.cr...@lpnt.netmailto:barbara.cr...@lpnt.net ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of barbara.cr...@lpnt.net Sent: Tuesday, June 28, 2011 8:54 AM To: histonet@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.cr...@lpnt.netmailto:barbara.cr...@lpnt.net ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] VENTANA ULTRA ER,PR,HER2
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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of barbara.cr...@lpnt.net Sent: Tuesday, June 28, 2011 10:54 AM To: histonet@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.cr...@lpnt.netmailto:barbara.cr...@lpnt.net ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet The information in this e-mail, and any attachments therein, is confidential and for use by the intended addressee only. If this message is received by you in error please do not disseminate or read further. Please reply to the sender that you have received the message in error, then delete the message. Although Catholic Health Services of Long Island attempts to sweep e-mail and attachments for viruses, it does not guarantee that either are virus-free and accepts no liability for any damage sustained as a result of viruses. Thank you. ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
RE: [Histonet] VENTANA ULTRA ER,PR,HER2
We will be going through this transition, here at Yuma Regional Medical Center.. Call me if you have questions Jesus Ellin 928-336-1743 -Original Message- From: histonet-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of barbara.cr...@lpnt.net Sent: Tuesday, June 28, 2011 7:54 AM To: histonet@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.cr...@lpnt.netmailto:barbara.cr...@lpnt.net ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet __ This message is confidential, intended only for the named recipient(s) and may contain information that is privileged or exempt from disclosure under applicable law. If you are not the intended recipient(s), you are notified that the dissemination, distribution, or copying of this message is strictly prohibited. If you receive this message in error, or are not the named recipient(s), please notify the sender at either the e-mail, fax, address, or telephone number listed above and delete this e-mail from your computer. Thank You. __ ___ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
