Illumina Inc, San Diego, has received the CE mark for its expanded VeriSeq noninvasive prenatal testing (NIPT) analysis software for clinical laboratories in the European Union (EU).
The updated 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 NIPT market.
The CE mark 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. The new software introduces a method that utilizes paired-end sequencing data.
“The update to the VeriSeq NIPT analysis software is another important milestone toward providing a more complete high-quality NIPT solution to our laboratory partners in the EU,” says 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 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.
According to the company, the software’s release represents an important step toward Illumina’s plan to provide a full CE marked NIPT solution. The upcoming VeriSeq NIPT system will include CE marked analyte-specific reagents with a supporting clinical accuracy study.
For more information, visit Illumina.