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-boun...@lists.utsouthwestern.edu [mailto:histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Walter Benton Sent: Monday, June 20, 2011 1:37 PM To: Bell, Lynne; Histonet (histonet@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) wben...@cua.md ________________________________________ From: histonet-boun...@lists.utsouthwestern.edu [histonet-boun...@lists.utsouthwestern.edu] On Behalf Of Bell, Lynne [lynne.b...@cvmc.org] Sent: Monday, June 20, 2011 1:28 PM To: Histonet (histonet@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 _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet CONFIDENTIALITY NOTICE: The information contained in this electronic message is intended solely for the personal and confidential use of the designated recipient(s) named above and may contain information that is protected from disclosure under applicable law. If you are not the intended recipient, or the employee or agent responsible for delivering it to the intended recipient, you are hereby notified that any dissemination, distribution or copying of this transmission is strictly prohibited. If you have received this transmission in error, please notify the transmitting person/department immediately by email or telephone (410) 581-5881 and delete the message without making a copy. _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet ----------------------------------------- Confidentiality Notice: The following mail message, including any attachments, is for the sole use of the intended recipient(s) and may contain confidential and privileged information. The recipient is responsible to maintain the confidentiality of this information and to use the information only for authorized purposes. If you are not the intended recipient (or authorized to receive information for the intended recipient), you are hereby notified that any review, use, disclosure, distribution, copying, printing, or action taken in reliance on the contents of this e-mail is strictly prohibited. If you have received this communication in error, please notify us immediately by reply e-mail and destroy all copies of the original message. Thank you. _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet
