Skip to main content
Premium Trial:

Request an Annual Quote

Illumina Secures CE Mark for VeriSeq NIPT

NEW YORK (GenomeWeb) – Illumina announced today that it has launched its noninvasive prenatal test, VeriSeq NIPT, as a CE-marked in vitro diagnostic in Europe. The test screens for trisomies 21, 18, and 13, as well as some sex chromosomal disorders at 10 weeks' gestation.

Earlier this year, Illumina said it had applied the CE mark to its VeriSeq NIPT software and that it could enable the processing of 48 samples. Now, however, the entire solution has the CE mark and the workflow includes automation that enables the processing of up to 96 samples at once. Results can be generated in around one day.

Tony Gordon, vice president of business development for CooperGenomics, said in a statement, that his firm planned to use the VeriSeq NIPT for its test, Serenity. "The advances offered by VeriSeq NIPT will allow us to provide results to our clinical partners faster, with high sensitivity and minimal test failures," he said.

Illumina said it conducted a clinical accuracy study of 3,100 samples to determine that VeriSeq NIPT yielded sensitive and specific results for trisomies 21, 13 and 18, and also demonstrated a high concordance for the sex chromosomal aneuploidies reported.

"With this validated, CE-IVD marked solution featuring CE-IVD library prep and analysis software, customers can now access highly reliable NGS-based NIPT in their own labs," added Jeff Hawkins, vice president and general manager of reproductive genetic health at Illumina. "With this new solution, laboratories can feel confident that they are providing expectant parents with a highly reliable technology that enables accurate results."