title: Rapid fluorescence in situ hybridisation (FISH) for HER2 (ERBB2) assessment in breast and gastro-oesophageal cancer.
abstract: 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.
authors.affiliation: Department of Pathology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA Geisel School of Medicine at Dartmouth, Hanover, NH, USA Norris Cotton Cancer Center, Lebanon, NH, USA.
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Tafe
authors.affiliation: Department of Pathology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
authors.forename: Heather B
authors.initials: HB
authors.lastname: Steinmetz
authors.affiliation: Department of Pathology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
authors.forename: Samantha F
authors.initials: SF
authors.lastname: Allen
authors.affiliation: Department of Pathology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
authors.forename: Betty J
authors.initials: BJ
authors.lastname: Dokus
authors.affiliation: Department of Pathology, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA Geisel School of Medicine at Dartmouth, Hanover, NH, USA Norris Cotton Cancer Center, Lebanon, NH, USA.
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Tsongalis
mesh_terms: D014408:Biomarkers, Tumor / Q000235:genetics*; D001706:Biopsy; D001943:Breast Neoplasms / Q000201:enzymology / Q000235:genetics* / Q000473:pathology; D004938:Esophageal Neoplasms / Q000201:enzymology / Q000235:genetics* / Q000473:pathology; D005260:Female; D005784:Gene Amplification; D015972:Gene Expression Regulation, Neoplastic; D006801:Humans; D017404:In Situ Hybridization, Fluorescence; D008297:Male; D011237:Predictive Value of Tests; D011933:Reagent Kits, Diagnostic; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics*; D013274:Stomach Neoplasms / Q000201:enzymology / Q000235:genetics* / Q000473:pathology; D013997:Time Factors; D015854:Up-Regulation; D057188:Workflow
chemical_list: D014408:Biomarkers, Tumor; D011933:Reagent Kits, Diagnostic; D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human
keywords: BREAST CANCER; FISH; MOLECULAR PATHOLOGY