TEST DIRECTORY

Submission method of estrogen receptor/progesterone receptor (IHC), breast cancer HER2/neu protein (staining method) and breast cancer HER2 gene (FISH)

• This test is to determine the treatment policy for cases for which a definitive diagnosis has been made by pathological test, so please fill in the pathological diagnosis name and tissue type on the pathological test request form before requesting.
• Since the presence or absence of cancer cells and the tissue type may be unknown, please attach a copy of the pathology report at the time of the test request. (However, this is not necessary if a general pathology test has been performed at our company.)
  If you are unable to attach the pathology report due to various reasons, please provide the name of the pathology diagnosis (tissue type, etc.) and as much clinical information as possible on the pathology test request form.
• The material should be unstained specimen slides (made from formalin-fixed paraffin blocks) of breast cancer (primary or metastatic). Please use silane or other coating slides, and after thinning, please dry the slides overnight at approximately 40°C before submitting them.
  The recommended fixation time is as follows in 10% neutral buffered formalin.

  【Fixation time】

  Item code	Test item	Time
  00A08 2 0A08 4	Estrogen receptor (IHC)	6-48 hours
  00A12 7 0A12 6	Progesterone receptor (IHC)	6-48 hours
  00A16 3 0A16 5	Estrogen receptor/progesterone receptor (IHC)	6-48 hours
  00A20 8 0A20 7	Breast cancer HER2/neu protein (staining method)	24-48 hours
  00A28 0 0A28 5	Breast cancer HER2 gene (FISH)	24-48 hours

• If you request immunohistochemical staining, please thin slice the tissue sections to a thickness of 4 µm.
  If FISH is requested, thin slice the tissue sections to a thickness of 4-6 µm.
  Tissue sections should be affixed in the center as much as possible.
• If you have already performed IHC or FISH test for breast cancer HER2, please indicate the test results on the request form.

Criteria

* HER2 Pathological Diagnostic Guidelines for Breast and Gastric Cancer, 2nd Edition (April 2021)