Dear Andrea,

The answer is no, the detection system does not need to be FDA approved.
If that were the case, none of the antibodies we use as adjunct aides to
morphological diagnosis would be the effective tools they have come to
be.  

I have done several inquiries on this subject, and the information I got
from a representative of Genentech, the company that makes Herceptin, is
that Her-2 testing does NOT have to be done with the Herceptest in order
for the patient to be a candidate for Herceptin.  The insert for the
drug states that "the Dako Herceptest....has not been directly studied
for its ability to predict Herceptin treatment effect, but has been
compared to the (Clinical Trial Assay used to IHC detection of Her-2
protein overexpression) on over 500 breast cancer histology specimens
obtained from the National Cancer Institute Cooperative Breast Cancer
Tissue Resource."   The insert then goes on to describe the "expected"
correlation results between Herceptest and the actual IHC Clinical Trial
Assay.

Genentech may be recommending Herceptest as the so called "assay of
choice", however the fact remains that there are other antibodies and
detection systems on the market that do a very good job detecting Her-2
overexpression much more economically than the Herceptest.


Diana Goodwin,  HT
Trenton,  NJ


> ----------
> From: 	Andrea Kelly[SMTP:canislupus@albanyonline.net]
> Sent: 	Tuesday, June 22, 1999 6:15 PM
> To: 	HistoNet Server
> Subject: 	Her2/neu
> 
> Can anyone explain the difference between the FDA approved Dako
> Herceptest
> and the other antibodies used for HER2/neu on automatic
> [immuno]stainers?
> Does it really matter whether the detection system is FDA approved or
> not?
> Thank you.
> 
>