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.net<mailto: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