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Illumina Applies CE Mark to VeriSeq NIPT Software

NEW YORK (GenomeWeb) – Illumina said today that an expanded version of its VeriSeq NIPT software to analyze fetal aneuploidies has met the requirements of the EU's in vitro diagnostic directive and it will apply the CE mark to the software.

The VeriSeq NIPT test is a noninvasive prenatal test that analyzes fetal aneuploidy for chromosomes 21, 18, 13, as well as the sex chromosomes.

The updated software includes a new method for processing samples and an increase in the number of samples it can batch from 16 to 48.

The update to the VeriSeq NIPT software "is another important milestone towards providing a more complete high-quality NIPT solution to our laboratory partners in the EU," Jeff Hawkins, Illumina's vice president and general manager of reproductive and genetic health, said in a statement. The updated software is a step toward a full CE-IVD marked test, which Illumina said would be supported by a clinical accuracy study.