MetaSystems Probes has received IVDR certification for our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
XL CLL Probe Kit (XL DLEU/LAMP/12cen + XL ATM/TP53)
Deletion/Enumeration Probe
- Order Number
- D-5044-100-TC
- Package Size
- 2x 100 µl (2x 10 Tests)
- Regulatory Status
- IVDD
IVDR Certification
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 CLL contains different probe mixes provided in separate test vials.
XL DLEU/LAMP/12cen consists of a green-labeled probe hybridizing to the centromere of chromosome 12, an orange-labeled probe hybridizing to the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 including D13S319 and an aqua-labeled probe hybridizing to the LAMP1 gene region at 13q34.
XL ATM/TP53 consists of a green-labeled probe hybridizing to the ATM gene region at 11q22.3 and an orange-labeled probe hybridizing to the TP53 gene region at 17p13.
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 XL CLL Probe Kit is a combination of probes covering the most frequent chromosomal aberrations in chronic lymphocytic leukemia (CLL). For a more detailed description, please refer to product XL DLEU/LAMP/12cen (D-5055-100-TC) and XL ATM/TP53 (D-5046-100-OG).
Clinical Applications
- Chronic Lymphocytic Leukemia (CLL)
- Multiple Myeloma and Plasma Cell Neoplasms (MM)
- Doehner et al (2000) N Engl J Med 343:1910-1916
- DeWald et al (2003) Brit J Haem 121:287-295
- Nelson et al (2007) Am J Clin Pathol 128:323-332
Certificate of Analysis (CoA)
or go to CoA DatabaseIVDR 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.