The ZytoLight Glioma 1p/19q Probe Set is intended to be used for the qualitative detection of deletions involving the human chromosomal region 1p36.31 as well as deletions involving the human chromosomal region 19q13.32-q13.33 in formalin-fixed, paraffin-embedded specimens, such as gliomas, by fluorescence in situ hybridization (FISH). The probe is intended to be used in combination with the ZytoLight FISH-Tissue Implementation Kit (Prod. No. Z-2028-5/-20). 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 gliomas and therapeutic measures should not be initiated based on the test result alone.