The firm has secured CE-IVD mark for VeriSeq NIPT analysis software to be used in clinical laboratories in the European Union (EU).

Illumina’s updated VeriSeq NIPT analysis software features an advanced method for processing samples. It can be used for larger batches of 48 samples against the current 16 samples.

VeriSeq NIPT analysis software will generate quantitative scores that will enable to detect and differentiate fetal aneuploidy status for chromosomes 21, 18, 13, X and Y.

It will analyze sequencing data generated from cell-free DNA fragments isolated from maternal peripheral whole blood specimens in pregnant women of at least ten weeks gestation.

According to the company, the upcoming VeriSeq NIPT solution will include CE-IVD marked assay specific reagents with a supporting clinical accuracy study.

Illumina reproductive and genetic health general manager and vice president Jeff Hawkins said: “The update to the VeriSeq NIPT Analysis Software is another important milestone towards providing a more complete high-quality NIPT solution to our laboratory partners in the EU.

“With this software, Illumina is enabling more clinical laboratories to implement NIPT testing efficiently and affordably in-house, increasing overall workflow efficiency and reducing the costs of testing.”

Llumina provides DNA sequencing and array-based technologies for customers in the research, clinical, and applied markets.