Comparison of PathVysion and INFORM fluorescence in situ hybridization kits for assessment of HER-2/neu status in breast carcinoma.
BACKGROUND
Fluorescence in situ hybridization is advocated for precise assessment of HER-2/neu status in breast carcinoma; however, few objective data compare available kits for clinical laboratories contemplating development of the test.


RESULTS
Thirty breast carcinomas were analyzed for HER-2/neu amplification with the PathVysion kit (Vysis, Downers Grove, IL) and INFORM kit (Ventana Medical Systems, Tucson, AZ). Each kit was evaluated for morphology, background staining, technical and interpretation time, and cost. PathVysion detected amplification in seven of 30 cases (23.3%); INFORM detected six of 30 cases (20%). A greater percentage of PathVysion cases showed good morphology and lower background staining than INFORM. Technical and interpretation times, as well as cost, were less with PathVysion than INFORM.


CONCLUSIONS
PathVysion is superior to INFORM because it produces better morphology and less background staining and is faster and less expensive than the INFORM kit. It also includes a chromosome 17 probe that serves as an internal control and enables correction for chromosome 17 aneuploidy.
Kakar
S
S
Department of Pathology, University of Illinois at Chicago, Chicago, IL 60612, USA.
Puangsuvan
N
N
Stevens
J M
JM
Serenas
R
R
Mangan
G
G
Sahai
S
S
Mihalov
M L
ML
D001943:Breast Neoplasms / Q000175:diagnosis* / Q000235:genetics / Q000648:ultrastructure; D002277:Carcinoma / Q000175:diagnosis* / Q000235:genetics / Q000648:ultrastructure; D002467:Cell Nucleus / Q000648:ultrastructure; D002886:Chromosomes, Human, Pair 17; D004273:DNA, Neoplasm / Q000032:analysis*; D005260:Female; D005784:Gene Amplification; D018734:Genes, erbB-2; D006801:Humans; D017404:In Situ Hybridization, Fluorescence / Q000191:economics / Q000379:methods*; D011933:Reagent Kits, Diagnostic / Q000191:economics / Q000592:standards*; D012680:Sensitivity and Specificity
D004273:DNA, Neoplasm; D011933:Reagent Kits, Diagnostic