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 BCL2 BA
Break Apart Probe
- Order Number
- D-6018-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1818
- 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 BCL2 BA break-apart probe is a qualitative, non-automated test for the detection of BCL2-rearrangements at 18q21.3 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 acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL) and non-Hodgkin-lymphomas (NHL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood for ALL and CLL and on sections of formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens or on methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.
The XL BCL2 BA break-apart probe consists of an orange-labeled probe hybridizing proximal to the BCL2 gene region at 18q21.3 and a green-labeled probe hybridizing distal to the BCL2 gene region at 18q21.3.
XL BCL2 BA hybridized to a prostate tissue section. The normal green-orange fusion signal pattern is observed.
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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