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 20A08 4
Estrogen receptor (IHC)
6-48 hours
00A12 70A12 6
Progesterone receptor (IHC)
6-48 hours
00A16 30A16 5
Estrogen receptor/progesterone receptor (IHC)
6-48 hours
00A20 80A20 7
Breast cancer HER2/neu protein (staining method)
24-48 hours
00A28 00A28 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.
2025/08/27→大原
2024/04/16
2025/08/27
2025/08/27
2025/08/27
2025/08/27
2025/08/27
-
2025/08/27
2025/08/27
2025/08/27
2025/08/27
-
未確認
2024/04/16
判定基準
スコア
染色パターン*
判定
0
染色像が認められない
陰性
≦10%の腫瘍細胞にかすかな/かろうじて認識できる不完全な膜染色が認められる
陰性 (超低発現)
1+
>10%の腫瘍細胞にかすかな/かろうじて認識できる不完全な膜染色が認められる
陰性 (低発現)
2+
>10%の腫瘍細胞に弱/中等度の全周性の膜染色が認められる
境界域
3+
>10%の腫瘍細胞に強い完全な全周性の膜染色が認められる
陽性
* 乳癌・胃癌HER2病理診断ガイドライン 第2版 (2021年4月)
Scoring criteria
Score
Breast and Gastric Cancer HER2 Pathology Diagnostic Guidelines,
2nd Edition (April 2021), staining patterns
0
Staining image is not found or ≤10% of
tumor cells have faint/barely recognizable incomplete membrane staining.
1+
>10% of tumor cells have faint/barely recognizable incomplete membrane staining.
2+
>10% of tumor cells show weak/moderate membrane staining in the entire circumference.
3+
>10% of tumor cells show strong, complete membrane staining in the entire circumference.