The XL 19p/19q del probe is a qualitative, non-automated test for the detection of deletions in the GLTSCR1/GLTSCR2 gene region at 19q13.3 and copy number variations of chromosome 19 by fluorescence in situ hybridization (FISH). A reference probe hybridizes to the ZNF443 gene region at 19p13.2. The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected solid tumors (e.g., gliomas), chronic lymphocytic leukemia (CLL), multiple myeloma (MM), myeloproliferative neoplasms (MPN). Hybridization is to be performed on sections of formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens or on methanol/acetic-acid fixed plasma cells for MM or on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood for MPN and CLL.

The XL 19p/19q del probe consists of a green-labeled probe hybridizing to the ZNF443 gene region at 19p13.2 and an orange-labeled probe hybridizing to the GLTSCR1/GLTSCR2 gene region at 19q13.3.

Probe maps for selected products have been updated. These updates ensure a consistent presentation of all gaps larger than 10 kb including adjustments to markers, genes, and related elements. This update does not affect the device characteristics or product composition. Please refer to the list to find out which products now include updated probe maps.

Probe map details are based on UCSC Genome Browser GRCh37/hg19, with map components not to scale.