RE: Breast specimens

From:"Willis, Donna"

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
Subject: Re: Breast specimens

Donna Willis, Histology Lab Manager, Harris Methodist, Fort Worth, Texas 

>>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
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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