Illumina, Inc has announced that it declared conformity with the requirements of the IVD Directive and has applied the CE mark to expand the use of VeriSeq NIPT Analysis Software in clinical laboratories. The CE marking signifies that the analysis software complies with the quality standards set by the European In Vitro Diagnostics Directive (98/79/EC), and certifies that it has been created and manufactured to meet strict safety and health criteria for distribution in the European Union (EU).
“This registration underscores our commitment to providing robust, high-quality solutions to meet the needs of our laboratory partners in the EU while meeting safety and quality requirements,” said Jeff Hawkins, Vice President and General Manager of Reproductive and Genetic Health at Illumina.
The software can be run in-lab on an on-site server and offers an accessible, secure and validated solution that analyzes sequencing information from cell-free DNA, without the need to upload information to a cloud. By using a sophisticated, proprietary algorithm, VeriSeq NIPT Analysis Software aids in the detection of fetal trisomies for chromosomes 21, 18 and 13, as well as sex chromosomal aneuploidy.
Currently, NIPT testing is available through several major labs around the world. The CE marking will enable more clinical laboratories to implement NIPT testing efficiently and affordably in their own labs, which can reduce the critical time to answer and make NIPT testing more broadly available.