XL RUNX1

Break Apart Probe

Order Number
D-5096-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosome
21
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 RUNX1 break-apart probe is a qualitative, non-automated test for the detection of RUNX1-rearrangements at 21q22.1 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 acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.

Product Description

The XL RUNX1 break-apart probe consists of an orange-labeled probe hybridizing proximal to the RUNX1 gene region at 21q22.1 and a green-labeled probe hybridizing distal to the RUNX1 gene region at 21q22.1.

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Images

XL RUNX1

XL RUNX1 was hybridized to lymphocytes. One normal interphase and metaphase are shown.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two green-orange colocalization/fusion signals (2GO).

Expected Pattern 2

Aberrant Cell (typical results):
One green-orange colocalization/fusion signal (1GO), one separate green (1G) and orange (1O) signal each resulting from a chromosome break in the respective locus.

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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