The ZytoDot SPEC ERBB2 Probe Kit is intended to be used for the qualitative detection of amplifications involving the human ERBB2 gene in formalin-fixed, paraffin-embedded specimens, such as breast cancer, by chromogenic in situ hybridization (CISH). The product is intended for professional use only. All tests using the product should be performed in a certified, licensed anatomic pathology laboratory under the supervision of a pathologist/human geneticist by qualified personnel. The probe is intended to be used as an aid to the differential diagnosis of breast cancer and therapeutic measures should not be initiated based on the test result alone.