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 DLEU/TP53
Deletion Probe
- Order Number
- D-5067-100-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 DLEU/TP53 probe is a qualitative, non-automated test for the detection of deletions of the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 and the TP53 gene region at 17p13 by fluorescence in situ hybridization (FISH). The product is intended as a diagnostic aid and assists in disease monitoring. The test population for the detection of deletions of the DLEU1/MIR15A/MIR16-1 gene region consists of patients with confirmed or suspected chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin-lymphomas (NHL). The test population for the detection of deletions of the TP53 gene region consists of patients with confirmed or suspected acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), myelodysplastic neoplasms (MDS), 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 ALL, AML, CLL and MDS, 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 DLEU/TP53 probe consists of an orange-labeled probe hybridizing to the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 including D13S319 and a green-labeled probe hybridizing to the TP53 gene region at 17p13.
XL DLEU/TP53 hybridized to bone marrow cells. A cell with normal signal pattern together with cells with a deletion of TP53 (2 orange, 1 green) and cells with deletions of TP53 and DLEU (1 orange, 1 green) are shown.
Normal Cell:
Two green (2G) and two orange (2O) signals.
Aberrant Cell (typical results):
Two green (2G) and one orange (1O) signal resulting from loss of one orange signal.
Aberrant Cell (typical results):
One green (1G) and two orange (2O) signal resulting from 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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