Illumina, Inc. (NASDAQ: ILMN) today announced the launch of the VeriSeq™ NIPT Solution, a CE-IVD marked next-generation sequencing (NGS)-based approach to noninvasive prenatal testing (NIPT), including CE-IVD marked library prep and analysis software, which enables laboratories in the European Union to bring efficient, highly accurate NIPT in-house. The automated comprehensive solution allows laboratories to screen for certain fetal chromosomal abnormalities in approximately one day.
The VeriSeq™ NIPT Solution provides accurate information about fetal chromosome status as early as 10 weeks gestation using a single maternal blood draw. This noninvasive screen yields results for trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome), as well as certain sex chromosome-related disorders. Due to its high-sensitivity and high-specificity (low false-positive and false-negative rates), NGS-based NIPT minimizes the need for invasive testing procedures.
"As a proud partner of Illumina, we are thrilled to soon use the new VeriSeq™ NIPT protocol to power our NIPT test, Serenity," said Tony Gordon, PhD, Vice President of Business Development for CooperGenomics. "The advances offered by VeriSeq™ NIPT will allow us to provide results to our clinical partners faster, with high sensitivity and minimal test failures."
By leveraging Illumina paired-end sequencing by synthesis chemistry and incorporating innovations in workflow, instruments and software, the VeriSeq™ NIPT Solution makes NGS-based NIPT accessible to any laboratory. The automated, reliable solution provides reagents, instruments, installation and training, and offers unprecedented turnaround times; laboratories can process up to 96 samples in approximately one day. To demonstrate performance, Illumina conducted a rigorous supporting clinical accuracy study of over 3,100 maternal samples which determined that the VeriSeq™ NIPT Solution not only provided highly sensitive and specific results for trisomies 21, 13 and 18, but also demonstrated a high concordance for the sex chromosomal aneuploidies reported.
"The VeriSeq™ NIPT Solution offers a rapid workflow and unprecedented automation that revolutionizes NIPT. With this validated, CE-IVD marked solution featuring CE-IVD library prep and analysis software, customers can now access highly reliable NGS-based NIPT in their own labs," said Jeff Hawkins, Vice President and General Manager of Reproductive Genetic Health at Illumina. "With this new solution, laboratories can feel confident that they are providing expectant parents with a highly reliable technology that enables accurate results."