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This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
MetaSystems Probes has already certified a large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.
XL 19p/19q del 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.
Probe maps are created in accordance with the intended purpose of the product. Solid colored bars do not necessarily indicate that the probe fully covers the indicated genomic region. Therefore, caution is advised when interpreting results generated through off-label use. Probe map details based on UCSC Genome Browser GRCh37/hg19. Map components not to scale. Further information is available on request.
The 2016 ´World Health Organization Classification of Tumors of the Central Nervous System´(WHO 2016) combines, for the first time, histological features and molecular signatures for the definition of many tumor entities. Gliomas are a category of tumors of the brain and spinal cord originating in glia cells. Oligodendrogliomas are a subtype of gliomas accounting for up to 18% of all cases. According to the WHO 2016, the classification of an oligodendroglioma requires information about the isocitrate dehydrogenase mutation status and 1p/19q loss of heterozygosity (LOH). LOH of 19q can be detected in about 80% of oligodendroglial tumors and to a lower extend in mixed gliomas. Co-deletion of 1p/19q is a well-accepted prognostic biomarker in neuro-oncology. Patients suffering from anaplastic oligodendroglioma harboring 1p/19q deletion generally have a good prognosis. Co-deletion of 1p/19q also has a predictive character, the molecular status of 1p/19q is relevant for therapy decisions.
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.
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.
We hope you had a chance to meet us.
The IVDR is effective and our probes stay the same! A large segment of our portfolio is already IVDR-certified. Our priority is to give you a smooth transition into the IVDR era.
