XL FGFR1

Break Apart Probe

Order Number
D-5041-100-OG
Package Size
100 µl (10 Tests)
Labels
  
Chromosome
8
Regulatory Status
IVDD

IVDR Certification

This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

MetaSystems Probes has already certified a large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.

Please use the switch to change to the IVDR product.

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Product Description

XL FGFR1

XL FGFR1 consists of a green-labeled probe hybridizing proximal to the FGFR1 gene region at 8p11.2 and an orange-labeled probe hybridizing distal to the FGFR1 gene region at 8p11.2.

Probe maps are created in accordance with the intended purpose of the product. Solid colored bars do not necessarily indicate that the probe fully covers the indicated genomic region. Therefore, caution is advised when interpreting results generated through off-label use. Probe map details based on UCSC Genome Browser GRCh37/hg19. Map components not to scale. Further information is available on request.

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Clinical Details

In 2008, the World Health Organization (WHO) classification of tumors of hematopoietic and lymphoid tissues introduced a new category for myeloid and lymphoid neoplasms with eosinophilia and abnormalities of PDGFRA, PDGFRB or FGFR1. Many of these cases present as a myeloproliferative neoplasm, usually with eosinophilia.

The 8p11 myeloproliferative syndrome (MPD) also known as stem cell leukemia-lymphoma syndrome (SCLL) is associated with translocations disrupting FGFR1. Imatinib, which induces durable responses in MPDs with PDGFRA and PDGFRB fusion genes, is inactive in patients with FGFR1 translocations.

Clinical Applications

  • Chronic Myelogenous Leukemia and Myeloproliferative Neoplasms (CML/MPN)
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Images

XL FGFR1

XL FGFR1 hybridized to bone marrow cells where a subpopulation with trisomy 8 was observed. One normal interphases is shown and one interphase with three fusion signals.

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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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Literature

  • Cross et al (2002) Leukemia 16:1207-1212
  • Walz et al (2005) Leukemia 19:1005-1009
  • Chase et al (2007) Blood 110:3729-3734

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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