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

Table 2 Comparison of HER2 signal quantification using dual-probe FISH between conventional-resolution and super-resolution image techniques

	Conventional-resolution images^a	Super-resolution images	p-value^b
Routine HER2-negative,^c median (min, max)
Nuclei with HER2 signals	10 (3;27)	12 (10; 29)	0.08
Nuclei with ambiguous HER2 signals	0 (0, 5)	0	0.15
HER2 signals	21 (7; 50)	34 (22; 62)	0.03
HER2 signals per nucleus	2.10 (1.85; 3.5)	2.82 (1.83; 3.93)	0.05
Nuclei with CEP17 signals	6.5 (2; 22)	10 (6; 27)	<0.01
Nuclei with ambiguous CEP17 signals	2 (0; 5)	0	0.02
CEP17 signals	10 (3; 41)	18 (11; 49)	<0.01
CEP17 signals per nucleus	1.64 (1.00; 2.00)	1.70 (1.27; 2.50)	0.37
HER2/CEP17 ratio	1.30 (1.02; 2.40)	1.72 (0.80; 2.36)	0.15
Routine HER2-positive,^c median (min, max)
Nuclei with HER2 signals	14 (2; 20)	15 (2; 29)	0.23
Nuclei with ambiguous HER2 signals	12 (1; 13)	0	0.01
HER2 signals	70 (8; 119)	134 (15; 162)	0.07
HER2 signals per nucleus	4 (3.50; 7.44)	7.5 (4.79; 10.80)	<0.05
Nuclei with CEP17 signals	5 (2; 13)	10 (2;22)	0.53
Nuclei with ambiguous CEP17 signals	0 (0; 1)	0	0.18
CEP17 signals	8 (4; 28)	20 (4; 49)	0.54
CEP17 signals per nucleus	2.00 (1.60; 2.15)	2.00 (1.80; 3.06)	0.57
HER2/CEP17 ratio	2.00 (1.79; 2.13)	2.73 (2.16; 5.61)	0.23

CEP17 Chromosome 17 centromere, FFPE Formalin-fixed paraffin-embedded, FISH Fluorescence in situ hybridization, HER2 Human epidermal growth factor receptor 2, max Maximum, min Minimum
^aThe image captured by HM-1000 fluorescence microscope without super-resolution processing
^bCalculated by Wilcoxon signed-rank test
^cDefined by routine FISH and IHC results following routine diagnostic criteria

ISSN: 1746-1596