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 7q22/7q36
Deletion Probe
- Order Number
- D-5043-100-TC
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 077
- 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 7q22/7q36 probe is a qualitative, non-automated test for the detection of deletions of the KMT2E gene region at 7q22, deletions of the CUL1/EZH2 gene region at 7q36 and monosomy 7 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 myeloid leukemia (AML), chronic myeloid leukemia (CML), chronic myelomonocytic leukemia (CMML), myelodysplastic neoplasms (MDS) and myelodysplastic/myeloproliferative neoplasms (MDS/MPN). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood.
The XL 7q22/7q36 probe consists of an orange-labeled probe hybridizing to the KMT2E gene region at 7q22, a green-labeled probe hybridizing to the CUL1/EZH2 gene region at 7q36 and an aqua-labeled probe hybridizing to the centromere of chromosome 7.
XL 7q22/7q36 hybridized to lymphocytes. Two normal interphases are shown.
Normal Cell:
Two Blue (2B), two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
Two blue (2B), one green (1G) and one orange (1O) signal resulting from the loss of one green and one orange signal.
Aberrant Cell (typical results):
One blue (1B), one green (1G) and one orange (1O) signal resulting from the loss of one chromosome.
Aberrant Cell (typical results):
Two blue (2B), two green (2G) and one orange (1O) signal resulting from the loss of one orange signal.
Aberrant Cell (typical results):
Two blue (2B), one green (1G) and two orange (2O) signals resulting from the loss of one green 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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