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Illumina Receives CE Mark to VeriSeq Analysis Software

January 31, 2017

San Diego–based, Illumina declared conformity with the requirements of the EU’s IVD directive and has qualified for the CE mark for an expanded VeriSeq NIPT analysis software for clinical laboratories in the European Union.

The software includes a method for processing samples and is designed for larger batches of 48 samples versus the current 16 samples.

The software generates quantitative scores to aid in the detection and differentiation of fetal aneuploidy status for chromosomes 21, 18, 13, X and Y by analyzing sequencing data generated from cell-free DNA fragments isolated from maternal peripheral whole blood specimens in pregnant women of at least 10 weeks gestation. — Cynthia Jessup

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