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 BCR/ABL1 plus
Translocation/Dual Fusion Probe
- Order Number
- D-5052-100-OG
- Package Size
- 100 µl (10 Tests)
- 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 BCR/ABL1 plus dual-fusion probe is a qualitative, non-automated test for the detection of BCR::ABL1-rearrangements, t(9;22)(q34.1;q11.2) 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 acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) and chronic myeloid leukemia and myeloproliferative neoplasms (CML/MPN). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XL BCR/ABL1 plus dual-fusion probe consists of an orange-labeled probe hybridizing to the ABL1 gene region at 9q34.1 and a green-labeled probe hybridizing to the BCR gene region at 22q11.2.
XL BCR/ABL1 plus hybridized to bone marrow cells. Two interphase cells with two fusion signals and separated orange and green signals each are shown, indicating a BCR::ABL1 translocation.
Normal Cell:
Two green (2G) and two orange signals (2O).
Aberrant Cell (typical results):
One green (1G), one orange (1O), and two green-orange colocalization/fusion signals (2GO) resulting from a reciprocal translocation between the respective loci.
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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