I am becoming confused about the FDA approval of Dako's HercepTest.  I
am hearing all sorts of rumors:

I heard that you don't need to use the Dako detection system for the
patient to receive treatment.

 I've heard that only 3+ staining validates treatment recommendation.

I've heard that 2+ and 3+ staining validates treatment recommendation.

I've heard that Zymed has a FDA approved c-erbB-2 antibody.  What kind
of FDA approval,  and can you substitute this antibody instead of using
Dako polyclonal antibody?

I've heard, if a pathologist does there own in-house study to validate
their method, they can substitute this procedure and the patient can
receive treatment; or they can screen with there antibody and validate
with Dako's HercepTest kit.

I would to get some feedback from some pathologist as well as from
anybody else who would like to respond.  However, I would like to get at
the truth.  I would like real data to support what the truth really is.

David Tacha HTL (ASCP)