Re: [Histonet] Joint guideline on testing for HER2 status in invasivebreast cancer

From:"Vinnie Della Speranza"

I have not read through the guideline which is quite a lengthy document but I'll comment on your questions with my best guess. others who've thoroughly studied the guideline are free to disagree.

my understanding and what I believe is the basis for the creation of this guideline is that previous lack of correlation of Her 2 results when comparing needle core results with lumpectomy. Our needle cores arrive in formalin and given their relatively small size, concern about adequate fixation of needle cores is much less likely to arise than the lumpectomy samples, which arrive unfixed and may sit before being grossed in and placed into formalin. This variation is largely the root cause of a failure of results to correlate between needle cores and the lumpectomy specimen, in my opinion.

In addition, it might be difficult for most labs to determine with any degree of accuracy exactly how much fixation time a needle core received since the lab can't control when the sample is introduced into formalin. not so with lumpectomy samples.

I believe the standard intends that lumpectomy specimens arrive at Pathology fresh and that these are to be cut down and placed in fixative with minimum delay. in addition, minimum and maximum fixation times are proposed (no less than six hours in formalin, no more than 48). if you typically start your processor on Friday evening with a delay start with tissues sitting in formalin, this upper fixation limit may be an issue for you.

in regard to your question " Does this mean that the sample that is not placed in cassettes is not to be fixed?" the answer is NO. they are just insisting that specimens be cut down to reasonable thicknesses before immersion in formalin.



Vinnie Della Speranza
Manager for Anatomic Pathology Services
Medical University of South Carolina
165 Ashley Avenue  Suite 309
Charleston, SC 29425
Ph: 843-792-6353
fax: 843-792-8974

>>> "Douglas D Deltour"  01/12/07 11:10AM >>>
Has anyone had a chance to decipher this new guideline for HER2 testing? I
think that overall it is a good idea but I have an issue with appendix E. It
says that "Fixation times for needle biopsies have not been addressed."  Why
put out a guideline when the initial HER2 testing is done on the needle


It also says "Breast specimens, after appropriate gross inspection and
designation of margins, should be promptly sliced at 5- to 10-mm intervals
and fixed in formalin (unsliced samples should not be fixed). The interval
between tissue acquisition and fixation of

breast specimens should be as short as possible." Am I off on this one by
thinking that "unsliced samples should not be fixed" means that the breast
should be delivered fresh? Does this mean that the sample that is not placed
in cassettes is not to be fixed? What do you do with the unsliced/unfixed
sample then? I need some coffee! Someone straighten me out. 


Douglas D. Deltour HT(ASCP)

Histology Supervisor

Professional Pathology Services, PC

One Science Court

Suite 200

Columbia, SC 29203


Fax (803)254-3262



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