Clinical application of the HM-1000 image processing for HER2 fluorescence in situ hybridization signal quantification in breast cancer

Table 3 Contingency table of super-resolution and conventional resolution FISH image evaluation

		Super-resolution FISH image evaluation
		Group 1	Group 2	Group 3	Group 4	Group 5
Conventional-resolution FISH image evaluation	Group 1	3
	Group 2		1
	Group 3
	Group 4
	Group 5		2			5
	Unevaluable	2				1

The observed HER2 and CEP17 signals categorize samples in five groups according to the 2018 ASCO/CAP HER2 testing guideline update; Group 1 (HER2/CEP17 ratio ≥ 2.0, HER2 signals/cell ≥ 4.0), Group 2 (HER2/CEP17 ratio ≥ 2.0, HER2 signals/cell < 4.0), Group 3 (HER2/CEP17 ratio < 2.0, HER2 signals/cell ≥ 6.0), Group 4 (HER2/CEP17 ratio < 2.0, HER2 signals/cell 4.0 - 6.0), Group 5 (HER2/CEP17 ratio < 2.0, HER2 signals/cell < 4.0). Group 1 defined as ISH positive and Group 5 as ISH negative. Group 2 – 4 required further evaluation by IHC

ISSN: 1746-1596