PT  - JOURNAL ARTICLE
AU  - Tafe, Laura J
AU  - Steinmetz, Heather B
AU  - Allen, Samantha F
AU  - Dokus, Betty J
AU  - Tsongalis, Gregory J
TI  - Rapid fluorescence in situ hybridisation (FISH) for <em>HER2 (ERBB2)</em> assessment in breast and gastro-oesophageal cancer
AID  - 10.1136/jclinpath-2014-202787
DP  - 2015 Apr 01
TA  - Journal of Clinical Pathology
PG  - 306--308
VI  - 68
IP  - 4
4099  - http://jcp.bmj.com/content/68/4/306.short
4100  - http://jcp.bmj.com/content/68/4/306.full
SO  - J Clin Pathol2015 Apr 01; 68
AB  - Evaluation of HER2 (ERBB2) gene amplification or protein expression is standard of care in breast (BR) and advanced stage gastro-oesophageal cancers to identify patients eligible for anti-HER2 therapies. Here, we evaluate a rapid fluorescence in situ hybridisation (FISH) technology (HER2 instant quality (IQ) FISH pharmDx Kit) for detection of HER2 in patients with BR and gastro-oesophageal cancer using 30 FFPE samples that had been previously evaluated with the PathVysion HER2 DNA Probe Kit. Cases were scored as positive (HER2:CEN-17 ≥2.0), negative (HER2:CEN-17 <2.0) or equivocal according to the ASCO/CAP 2013 BR cancer guidelines. Ten samples were positive for HER2 amplification while 20 were negative; none were equivocal. The IQ FISH was able to detect low level amplification (HER2:CEN-17 ratio 2.4). The HER2 IQ FISH pharmDx Kit is a FDA approved kit that offers a rapid turnaround time (approximately 3.5 h) and in our laboratory was 100% concordant with prior PathVysion results.