David,

Thank you for your comments regarding HercepTest.  If anyone has additional
questions or concerns about HercepTest, please feel free to call technical
services at DAKO at 800-424-0021 or call me at 800-235-5743.  HercepTest
Facts, a newsletter produced every two months, is also available from DAKO.
The newsletter is intended to address current issues surrounding HercepTest
and HER2 testing.  HercepTest Facts can be requested by calling 800-235-5743
ext. 5422 or by contacting litreq@dakousa.com <mailto:litreq@dakousa.com> .


Sarah Sharif
Product Specialist, Clinical Diagnostics
DAKO Corporation
sarah.sharif@dakousa.com <mailto:sarah.sharif@dakousa.com> 

		-----Original Message-----
		From:	Dave Tacha [mailto:dtacha@ncal.verio.com]
		Sent:	Tuesday, July 20, 1999 8:16 AM
		To:	histonet@Pathology.swmed.edu
		Subject:	c-erbB-2 Response

		Thanks to all who responded about c-erbB-2 dilemma.

		Summary of Responses:

		1.  It appears that the Dako c-erbB-2 is an FDA premarket
approved (PMA)
		kit, which is much more extensive than 510K approval.

		 2.  However, individual laboratories do not have to use
Dako's PMA
		Herceptin Kit, and patients can received treatment by using
their own
		in-house methods.  However, the Dako kit has been tested and
approved
		with extensive clinical trials, and it is probably advisable
and it is
		highly recommended to use.

		3.  If an individual laboratory does not want to use Dako's
kit, it is
		highly recommended that the individual laboratory does a
side by side
		and/or validation study. If you choose not to,  you may be
taking risk
		that potentially may put patient health care at risk.

		4.  A written protocol for in-house studies should be
established.
		Below is a sample test for c-erbB-2 or any in-house
validation method
		for prognostic antibodies.  As technologists and health care
providers,
		I think it is important that we establish some sort of
validation
		criteria not only for c-erbB-2, but other assays such as ER
and PR and
		Ki-67.


		    A.  A suggested in-house validation method:

		    Stain a minimum of 20-30 cases of c-erbB-2 positive and
negative
		tissues with your standard and/or existing laboratory
		    protocol and compare results with the Dako kit.  A side
by side and
		comparison study should be done to validate your
		    in-house protocol.

		    You can also send cases to a reference lab, such as
Impath, for
		validation.

		    After validation testing, the individual laboratory can
use there
		own protocol and/or screen with their own protocol first,
and
		    then confirm with the Dako kit.

		5.  No one, including Zymed, has not responded  to the rumor
that Zymed
		has an FDA approved c-erbB-2 antibody.  One can only assume
that this
		was a rumor without substantiation.

		6.  Although studies have found that the 3+ staining
criteria is best
		for patient response to treatment with Herceptin, 2+'s are
not excluded
		by any "law".


		The above information was a summary of information received
from a
		Histonet response, including a response from Sarah Sharif,
Product
		Specialist from Dako Corporation.

		If there is any additional information that needs to be
stated, and/or
		if any of the above information is incorrect, your response
will be most
		appreciated.

		David Tacha HTL (ASCP)
		Biocare Medical