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.

The XL CLL probe contains 2 different probe mixes provided in separate vials.

XL ATM/TP53 (D-5046-100-OG): The XL ATM/TP53 probe consists of a green-labeled probe hybridizing to the ATM gene region at 11q22.3 and an orange-labeled probe hybridizing to the TP53 gene region at 17p13.

XL DLEU/LAMP/12cen (D-5055-100-TC): The XL DLEU/LAMP/12cen probe consists of a green-labeled probe hybridizing to the centromere of chromosome 12, an orange-labeled probe hybridizing to the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 including D13S319 and an aqua-labeled probe hybridizing to the LAMP1 gene region at 13q34.

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.