US-based healthcare company Illumina has introduced its next-generation sequencing (NGS) based solution to non-invasive prenatal testing (NIPT) called VeriSeq NIPT, along with the library prep and analysis software in Europe.
The automated solution is designed to screen for select fetal chromosomal abnormalities in about one day and provide chromosome status as early as ten weeks gestation from a single maternal blood draw.
The screen shows results for trisomy 21 (Down's syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau syndrome), and certain disorders associated with sex chromosome.
The high-sensitivity and high-specificity properties of the solution will help in reducing the requirement for invasive testing procedures.
Illumina Reproductive Genetic Health vice-president and General Manager Jeff Hawkins said: “The VeriSeq NIPT solution offers a rapid workflow and unprecedented automation that revolutionises 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.
"With this new solution, laboratories can feel confident that they are providing expectant parents with a highly reliable technology that enables accurate results.”
VeriSeq NIPT employs the firm's paired-end sequencing by synthesis chemistry with new workflow, instruments and software, making it available to any laboratory.
With the capacity to process 96 samples in around one day, the solution includes reagents, instruments, installation and training, as well as significant turnaround times.
The clinical study performed in more than 3,100 maternal samples showed that VeriSeq NIPT is highly sensitive and gives accurate results for trisomies 21, 13, 18, and sex chromosomal aneuploidies.