Our Complete Set of XA Aneusomy Probes for Prenatal Testing Is IVDR Certified.
At MetaSystems Probes, we have already certified a large segment of our XCyting FISH probe portfolio in accordance with the In Vitro Diagnostic Regulation (IVDR - Regulation (EU) 2017/746) and continue to work on the successive IVDR certification of our products. Our latest success is the IVDR certification of our XCyting FISH probes for prenatal aneusomy testing – the XA aneusomy probes.
We offer six different XA probe mixes and three different XA AneuScore probe kits so that you can choose the probes that best fit your routine. You even have the option for a centromere-labeling or a locus-specific-labeling for chromosome 18, a feature only available from us. Locus-specific probes can avoid variations in signal size that can be caused by polymorphic alpha satellite sequences when using centromeric probes1.
Open the list of all IVDR certified XCyting FISH probes.
Download our extended brochure about the portfolio of IVDR certified products.
Questions?
Please let us know if you have further questions regarding the IVDR transition, or if you would like to have an update on which probes are already IVDR certified. Simply send an email to IVDR@metasystems-probes.com.
1 Stumm et al., Cytogenet Genome Res 114:296–301 (2006). DOI: 10.1159/000094217.
Related Links
- Overview of the probes that have already received IVDR certification.
- Download brochure about the portfolio of IVDR certified products.
- Download IVDR certificate here.