XL ATM/TP53

Deletion Probe

Order Number
D-5046-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosomes
1117
Regulatory Status
IVDR

IVDR Certification

This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). For organizational reasons, we currently provide only the IVDD product.

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Intended Purpose

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.

Product Description

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.

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Images

XL ATM/TP53

XL ATM/TP53 hybridized to bone marrow cells. Four interphases are shown of which two show a normal signal pattern. The two other interphases show aberrant signal patterns with a deletion of ATM in one cell and a deletion of TP53 in the other one.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two green (2G) and two orange (2O) signals.

Expected Pattern 2

Aberrant Cell (typical results):
One green (1G) and two orange (2O) signal resulting from loss of one green signal.

Expected Pattern 3

Aberrant Cell (typical results):
Two green (2G) and one orange (1O) signal resulting from loss of one orange signal.

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Downloads

News


IVDR Certification

MetaSystems Probes has received IVDR certification for our initial 26 fluorescence in situ hybridization (FISH) probes from the notified body, BSI. Achieving this milestone was not without its challenges, and we are delighted to have accomplished IVDR certification for this probe set at an early stage.

IVDR Certification