RE: Breast specimens
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.
Histology Lab Manager
Harris Methodist Fort Worth, Texas
From: RSRICHMOND@aol.com [mailto:RSRICHMOND@aol.com]
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...
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