XL MDM2

Enumeration Probe

Order Number
D-5047-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosome
12
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 MDM2 enumeration probe is a qualitative, non-automated test for the detection of copy number variations of the MDM2 gene region at 12q15 and of chromosome 12 by fluorescence in situ hybridization (FISH). 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). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.

Product Description

The XL MDM2 enumeration probe consists of an orange-labeled probe hybridizing to the MDM2 gene region at 12q15 and a green-labeled probe hybridizing to the centromere of chromosome 12.

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Images

XL MDM2

XL MDM2 hybridized to lymphocytes. Two normal interphases and one normal metaphase are shown.

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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):
Two green (2G) and three orange (3O) signals resulting from gain of one orange signal.

Expected Pattern 3

Aberrant Cell (typical results):
Three green (3G) and three orange (3O) signals each resulting from a gain of one green signal and one orange signal.

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