Re: Her2/neu

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From:"Peter A. Takes" <>
To:Andrea Kelly <>
Date:Wed, 23 Jun 1999 09:38:26 -0500
Content-Type:text/plain; charset=us-ascii


I don't know the difference between Dako's product and others; probably a
different clone and possibly different performance characteristics.  How it
actually performs is dependent on how the antibody is supplied (e.g.,
concentration, titer, etc.).

There are a few advantages to FDA approval/clearance.  First, if you are a
clinical lab, many states have invoked rules where IHC tests will not be
reimbursed if FDA-cleared antibodies are not used in diagnostic tests.  This
is the result of recent new FDA rules regarding IHC Abs, and HCFA attention to
IHC and Abs.  Thus, many Ab manufacturers have or are pursuing FDA clearance
on the use of their reagents in diagnostic testing.  Dako and Ventana are two
of the most aggressive companies in this pursuit.  Keep in mind, FDA
approval/clearance does not endorse the performance or use of any individual
reagents, but does attest that individual companies have provided to the
Agency sufficient information that assumes proper performance evaluation of
the reagents has been completed to support the antibody's indicated use.

Hope this answers your questions.

Peter A. Takes, Ph.D., RAC
Director, Clinical & Regulatory Affairs
Ph. 1-314-615-6964; Pager: 841-9351

Andrea Kelly wrote:

> 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.

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