XL KMT2A BA

Break Apart Probe

Order Number
D-5090-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosome
11
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.

Please use the switch to change to the IVDD product.

IVDDIVDR

Intended Purpose

The XL KMT2A BA break-apart probe is a qualitative, non-automated test for the detection of KMT2A-rearrangements at 11q23.3 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 KMT2A BA break-apart probe consists of an orange-labeled probe hybridizing proximal to the KMT2A gene region at 11q23.3 extending into the gene up to intron 24 and a green-labeled probe hybridizing distal to the KMT2A gene region at 11q23.3 extending into the gene up to intron 20 and thus overlapping each other for 3.4kb (GRCh37/hg19).

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Images

XL KMT2A BA

XL KMT2A BA hybridized to bone marrow cells, one aberrant cell is shown. A cryptic insertion of KMT2A is observed generating a signal pattern of two orange-green colocalization/fusion signals and one additional orange signal.

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Expected Patterns

Expected Pattern 1

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

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. Translocations with breakpoints within the KMT2A breakpoint cluster region result in a small orange split signal remaining with the separated green signal. The residual orange signal is significantly smaller than the separated orange signal and might even be invisible.

Expected Pattern 3

Aberrant Cell (typical results):
Two green-orange colocalization/fusion signals (2GO) and one separate usually small orange (1O) signal indicating an insertion of the respective genomic region to an unknown chromosome.

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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

New Probes Catalog is Online!

 

MetaSystems Probes is pleased to announce the new catalog including new and innovative products and supporting information. A PDF version of the new catalog is available for download here.

New Probes Catalog is Online!