CE-IVD marked software utilizes paired-end sequencing data for clinical labs in the EU
Illumina, Inc. (NASDAQ: ILMN) today announced that it has declared conformity with the requirements of the IVD Directive and has applied the CE mark to an expanded VeriSeq™ NIPT Analysis Software for clinical laboratories in the European Union (EU). This updated VeriSeq™ NIPT Analysis Software includes an innovative method for processing samples and is designed for larger batches of 48 samples, versus the current 16 samples, which can scale to meet the future demands of the growing noninvasive prenatal testing (NIPT) market. Using this software, clinical labs in the EU have access to fast and reliable software for analysis of sequencing data for NIPT.
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 EU. This new software introduces a method that utilizes paired-end sequencing data.
“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,” said Jeff Hawkins, Vice President and General Manager of Reproductive and Genetic Health at Illumina. “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.”
The VeriSeq™ NIPT Analysis 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.
The release of the VeriSeq™ NIPT Analysis Software (48 Samples) represents an important step toward Illumina’s plan to provide a full CE-IVD NIPT solution. The upcoming VeriSeq™ NIPT Solution will include CE-IVD marked assay specific reagents with a supporting clinical accuracy study.