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 MYC BA triple-color
Break Apart Probe - Triple Color
- Order Number
- D-6030-100-TC
- 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 MYC BA triple-color break-apart probe is a qualitative, non-automated test for the detection of MYC-rearrangements at 8q24.21 by fluorescence in situ hybridization (FISH). The probe design also allows differentiation of the location of the breakpoint. The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin lymphomas (NHL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood for CLL, on methanol/acetic-acid fixed plasma cells for MM and on sections of formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens or methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.
The XL MYC BA triple-color break-apart probe consists of an orange-labeled probe hybridizing proximal to the MYC gene region at 8q24.21, an aqua-labeled probe hybridizing to the MYC gene region at 8q24.21 and a green-labeled probe hybridizing distal to the MYC gene region at 8q24.21.
XL MYC BA triple-color hybridized to lymphocytes. One nucleus shows the normal two green-orange-blue signals, the other nucleus shows a separated green signal indicating a break distal to the MYC gene region.
Normal Cell:
Two green-orange-blue colocalization/fusion signals (2GOB).
Aberrant Cell (typical results):
One green-orange-blue colocalization/fusion signal (1GOB), one green-blue colocalization/fusion (1GB) and one separate orange (1O) signal resulting from a chromosome break in the respective locus.
Aberrant Cell (typical results):
One green-orange-blue colocalization/fusion signal (1GOB), one one separate green (1G) and one orange-blue colocalization/fusion (1OB) signal resulting from a chromosome break in the respective locus.
Aberrant Cell (typical results):
One green-orange-blue colocalization/fusion signal (1GOB), one green-blue colocalization/fusion (1GB) and one orange-blue colocalization/fusion (1OB) signal resulting from a chromosome break in therespective 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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