XL t(8;9) PCM1/JAK2 DF

Translocation/Dual Fusion Probe

Order Number
D-5120-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosomes
89
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 t(8;9) PCM1/JAK2 DF dual-fusion probe is a qualitative, non-automated test for the detection of PCM1::JAK2-rearrangements, t(8;9)(p22;p24) 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 myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions (MLN-TK), 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 t(8;9) PCM1/JAK2 DF dual-fusion probe consists of an orange-labeled probe hybridizing to the PCM1 gene region at 8p22 and a green-labeled probe hybridizing to the JAK2 gene region at 9p24.

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Images

XL t(8;9) PCM1/JAK2 DF

XL t(8;9) PCM1/JAK2 DF hybridized to bone marrow cells, one aberrant cell is shown. A translocation t(8;9) has occurred generating a signal pattern of two colocalization/fusion signals, one green and one orange signal.

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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), one orange (1O), and two greenorange colocalization/fusion signals (2GO) resulting from a reciprocal translocation between the respective loci.

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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!