CE-IVD marked software utilizes paired-end sequencing data for clinical labs in the EU
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
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.
About Illumina, Inc.
Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical, and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.
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