Gynecologic biomarkers testing click to access further explanations in the original CAP template

- For ER/PR, POSITIVE is >= 1%

Low-power, observed within a homogeneous and contiguous population of invasive tumor cells.

Based on the enrollment criteria for Trastuzumab in the randomized phase II clinical trial NCT01367002 for endometrial carcinoma HER2 Status for Trastuzumab Use

Negative (score 0) for protein overexpression
No staining in tumor cells

Negative (score 1+) for protein overexpression
Faint / barely perceptible, incomplete membrane staining in any proportion, or weak complete staining in less than 10% of tumor cells

Equivocal (score 2+) for protein overexpression
Strong complete or basolateral / lateral membrane staining in less than or equal to 30%, or weak to moderate staining in greater than or equal to 10% of tumor cells

Positive (3+) for protein overexpression
Strong complete or basolateral / lateral membrane staining in greater than 30% of tumor cells


Negative (score 0) for protein overexpression
Biopsy: No staining in any tumor cells;
Surgical specimen: No staining or membrane staining in less than 10% of tumor cells

Negative (score 1+) for protein overexpression
Biopsy: Tumor cell cluster (5 or more tumor cells) with a faint / barely perceptible membrane staining irrespective of percentage of positive tumor cells;
Surgical specimen: Faint / barely perceptible incomplete membrane staining in greater than or equal to 10% tumor cells

Equivocal (score 2+) for protein overexpression
Biopsy: Tumor cell cluster (5 or more tumor cells) with a weak to moderate, complete, basolateral or lateral membrane staining irrespective of percentage of positive tumor cells;
Surgical specimen: Weak to moderate, complete, basolateral or lateral membrane staining in greater than or equal to 10% of tumor cells

Positive (3+) for protein overexpression
Biopsy: Tumor cell cluster (5 or more tumor cells) with a strong, complete, basolateral or lateral membrane staining irrespective of percentage of positive tumor cells;
Surgical specimen: Strong, complete, basolateral or lateral membrane staining in greater than or equal to 10% of tumor cells


+ HER2/neu oncoprotein DISH :
HER2 DISH calculator


NEGATIVE: FISH HER2/CEP17 ratio less than 2.0 and Average HER2 copy number < 6/nucleus
POSITIVE: FISH HER2/CEP17 ratio greater than or equal to 2.0 OR FISH HER2/CEP17 ratio less than 2.0 with average HER2 copy number >= 6/nucleus
- Number of tumor cells counted :
- Average HER2 signals (black) per nucleus :
- Average CEP17 signals (red) per nucleus :
- HER2/CEP17 ratio :
- Other ISH abnormalities:




*Note that hereditary colon cancer clinic is using slightly different markers for MSI: Six mononucleotide repeat (BAT25, BAT26, SLC7A8, NR-21), TMPPB5 (NR-22), ZNF-2 (NR-24) and BAT40, and three dinucleotide repeats (D2S123, D5S346, D17S250).


PD-L1 calculator
Please specify if alternate scoring system was used.
CPS = Total positive cells / (Positive cells + Negative tumor cells). CPS >=1 is POSITIVE.
min
hours

Positive percentage
(from Roche document SP263 manual)

+ Ancillary studies include BRCA1 and BRCA2 germline and somatic mutation testings and POLE hot spot mutations

DOWNLOAD THE EXCEL FILE for HER2 DISH

DOWNLOAD THE EXCEL FILE for PD-L1 IHC test