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 ETV6 BA
Break Apart Probe
- Order Number
- D-5139-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1212
- 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 ETV6 BA break-apart probe is a qualitative, non-automated test for the detection of ETV6-rearrangements at 12p13.2 and deletions of 12p13.2 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 acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), myelodysplastic neoplasms (MDS), multiple myeloma (MM), myeloproliferative neoplasms (MPN) 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, AML, CMML, MDS and MPN, on methanol/acetic-acid fixed plasma cells for MM and on methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.
The XL ETV6 BA break-apart probe consists of an orange-labeled probe hybridizing proximal to the ETV6 gene region at 12p13.2 and a green-labeled probe hybridizing distal to the ETV6 gene region at 12p13.2 extending into the 5'gene region.
XL ETV6 BA hybridized to lymphocytes. One normal interphase and one normal metaphase are shown.
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.
Aberrant Cell (typical results):
One green-orange (1GO) colocalization/fusion signal and one orange (1O) signal resulting from the loss of one green signal.
Aberrant Cell (typical results):
One green-orange colocalization/fusion signal (1GO) resulting from the loss of one green signal and one orange signal.
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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