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 19p/19q del
Deletion/Enumeration Probe
- Order Number
- D-6019-100-OG
- Package Size
- 100 µl (10 Tests)
- Chromosome
- 1919
- 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 19p/19q del probe is a qualitative, non-automated test for the detection of deletions in the GLTSCR1/GLTSCR2 gene region at 19q13.3 and copy number variations of chromosome 19 by fluorescence in situ hybridization (FISH). A reference probe hybridizes to the ZNF443 gene region at 19p13.2. The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected solid tumors (e.g., gliomas), chronic lymphocytic leukemia (CLL), multiple myeloma (MM), myeloproliferative neoplasms (MPN). Hybridization is to be performed on sections of formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens or on methanol/acetic-acid fixed plasma cells for MM or on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood for MPN and CLL.
The XL 19p/19q del probe consists of a green-labeled probe hybridizing to the ZNF443 gene region at 19p13.2 and an orange-labeled probe hybridizing to the GLTSCR1/GLTSCR2 gene region at 19q13.3.
XL 19p/19q del hybridized to oligodendroglioma tissue. Loss of heterozygosity of 19q is indicated by the loss of one orange signal.
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):
Three green (3G) and three orange (3O) signals each resulting from a gain 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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