RE: Breast specimens

From:"Horn, Hazel V"

And would require the language of the ASR to be in the path report stating
that it is not an FDA approved test.    I believe this to very important to
BC patients.    As a survivor (and a histotech),  I follow all of these
issues very closely.
Hazel Horn

> -----Original Message-----
> From:	Willis, Donna []
> Sent:	Thursday, April 25, 2002 3:40 PM
> To:	'';
> Subject:	RE: Breast specimens
> Bob,
> Thanks for the question.  Since we use HER2/neu in our lab as an ASR, I
> have
> done a little more research on the formalin fixation and you are correct.
> The Herceptest and Pathway package inserts/protocols are very detailed
> about
> the amount of time that a sample must be " formalin" fixed. Microwaving a
> sample would change the approved time. I highly suggest that anyone
> performing HER2/neu and reporting it out as a FDA approved procedure, make
> sure you are following the procedure according to manufacture guideline.
> If
> you change the procedure it is not FDA approved and is considered an ASR.
> Some states require FDA methods and to get the correct reimbursement from
> Medicare you have to use this method.
> Thanks Again,
> Donna Willis
> Histology Lab Manager
> Harris Methodist Fort Worth, Texas
> -----Original Message-----
> From: []
> Sent: Thursday, April 25, 2002 12:50 PM
> To:
> Subject: Re: Breast specimens
> Donna Willis, Histology Lab Manager, Harris Methodist, Fort Worth, Texas 
> notes:
> >>When using the FDA approved DAKO Herceptest [for HER2/neu,] or the FDA 
> Ventana Pathway method, you have to use formalin as the fixative. - In our
> lab we make sure the specimen is fixed properly by using microwave
> technology 
> before the samples are placed on the tissue processor.<<
> I'm not sure it makes any difference, but microwaving is a form of
> fixation,
> and could be considered an irregular fixation method for the FDA approved 
> test. I'd at least want to run some samples in parallel to find out if it 
> alters the results. Remember always that the USA has 5% of the world's 
> population and 75% of its lawyers...
> Bob Richmond
> Samurai Pathologist
> Knoxville TN

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