The XL ATM/TP53 probe is a qualitative, non-automated test for the detection of deletions of the ATM gene region at 11q22.3 and the TP53 gene region at 17p13 by fluorescence in situ hybridization (FISH). The product is intended as a diagnostic aid and assists in disease monitoring. The test population for the detection of deletions of the ATM gene region at 11q22.3 consists of patients with confirmed or suspected chronic lymphocytic leukemia (CLL), T-cell prolymphocytic leukemia (T-PLL) and non-Hodgkin-lymphomas (NHL). The test population for the detection of deletions of the TP53 gene region consists of patients with confirmed or suspected acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), myelodysplastic neoplasms (MDS), multiple myeloma (MM) and non-Hodgkin-lymphomas (NHL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood for ALL, AML, CLL, T-PLL and MDS, on methanol/acetic-acid fixed plasma cells for MM and on methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.
The XL DLEU/LAMP/12cen probe is a qualitative, non-automated test for the detection of copy number variations of chromosome 12 and deletions of the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 by fluorescence in situ hybridization (FISH). The LAMP1 gene region at 13q34 is included as a reference. The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected chronic lymphocytic leukemia (CLL) and non-Hodgkin-lymphomas (NHL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood for CLL and on methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.