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.
XL FGFR1
Break Apart Probe
- Order Number
- D-5041-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 088
- 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.
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.
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)
Normal Cell:
Two green-orange colocalization/fusion signals (2GO).
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.
- Cross et al (2002) Leukemia 16:1207-1212
- Walz et al (2005) Leukemia 19:1005-1009
- Chase et al (2007) Blood 110:3729-3734
Certificate of Analysis (CoA)
or go to CoA Database