All of the following are FDA approved for In Situ testing:
PathVysion HER-2 DNA Probe Kit - Abbott Molecular United States (Des Plaines, Illinois)
Fluorescence in situ hybridization (FISH) assay used to determine HER2 amplification, using the locus specific HER2 probe, which spans HER2 gene and the centromere 17 probe, which hybridizes to the alpha satellite DNA located at the centromere of chromosome.
HER2 FISH pharmDx™ Kit - Agilent Dako Corporate Headquarters (Glostrup, Denmark)
FISH assay used to determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast cancer specimens.