XL 4q12 DC

Translocation/Deletion Probe

Order Number
D-5123-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosome
4
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 4q12 DC probe is a qualitative, non-automated test for the detection of deletions of the CHIC2 gene region at 4q12 and breaks in PDGFRA at 4q12 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 myelomonocytic leukemia (CMML), myelodysplastic/myeloproliferative neoplasms (MDS/MPN) and myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase gene fusions (MLN-TK). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.

Product Description

The XL 4q12 DC probe consists of a green-labeled probe hybridizing proximal to the FIP1L1 gene region at 4q12, an orange-labeled probe hybridizing to the CHIC2 gene region at 4q12 and another green-labeled probe hybridizing to the PDGFRA gene region at 4q12.

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Images

XL 4q12 DC

XL 4q12 DC hybridized to lymphocytes. Two normal interphases and one 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 (1GO) colocalization/fusion signal and one green (1G) signal resulting from the loss of one orange signal.

Expected Pattern 3

Aberrant Cell (typical results):
One green (1G) and two green-orange colocalization/fusion signals (2GO) signals resulting from a translocation between the green labeled PDGFRA gene region and an unknown chromosome.

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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