Illumina and Next Generation Genomic (NGG Thailand) are set to launch a next-generation sequencing (NGS)-based VeriSeq NIPT Solution v2 in the country.
The CE-IVD marked, automated in-lab solution is said to deliver precise, rapid and scalable end-to-end, genome-wide, non-invasive prenatal testing (NIPT).
It will permit NGG Thailand to introduce the Qualifi Prenatal Test and become the first lab in South East Asia to identify anomalies that are missed by targeted assays.
As against traditional NIPT offerings, the test could offer additional insights into the health of a pregnancy.
Leveraging Illumina’s NIPT solution, the test provides a complete view of the foetal genome when compared with other CE-IVD NIPT products. This facilitates healthcare professionals to provide expectant parents with informed, timely and tailored pregnancy management options.
Illumina noted that standard prenatal screening has limited capability to check beyond aneuploidies of chromosomes 21, 18 and 13.
The non-invasive Qualifi Prenatal Test delivers precise data about foetal chromosomal status at ten weeks of pregnancy with the help of a single maternal blood draw.
This test offers a whole-genome sequencing approach to NIPT, increasing prenatal screening to all rare autosomal aneuploidies, sex chromosome aneuploidies and large partial duplications and deletions.
Illumina Asia Pacific and Japan vice-president and general manager Gretchen Weightman said that the availability of VeriSeq NIPT Solution v2 is a significant milestone in the company’s alliance with NGG Thailand.
Weightman noted: “Illumina’s comprehensive technologies, coupled with NGG Thailand’s expertise, will enable healthcare providers and expectant parents to unlock the most critical information possible today.”
For assessing the clinical accuracy of the VeriSeq NIPT Solution v2, 2,300 plasma samples from pregnant women with singleton and twin pregnancies were analysed.
The samples were taken from women who underwent prenatal screening for foetal chromosome aneuploidies and partial deletions and duplications of 7Mb or greater.
Findings showed that the solution delivered highly sensitive and specific results with 98.8% passing assay quality control on the first pass.
Apart from Thailand, the NIPT solution is authorised in certain European countries, Australia, South Korea, New Zealand, Singapore, Israel and South Africa.
In April, Illumina and Kartos Therapeutics partnered to co-develop a NGS-based TP53 companion diagnostic (CDx) for various hematologic indications.