MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
Our Complete Set of XA Aneusomy Probes for Prenatal Testing Is IVDR Certified.
XL FGFR1
Break Apart Probe
- Order Number
- D-5041-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 088
- 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.
The XL FGFR1 break-apart probe is a qualitative, non-automated test for the detection of FGFR1-rearrangements at 8p11.2 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.
The XL FGFR1 break-apart probe 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.
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.
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.
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.
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