01 June 2021 | Tuesday | News
Illumina's VeriSeq NIPT Solution v2
llumina, Inc., the global leader in DNA sequencing and array-based technologies and Next Generation Genomic Co., Ltd. (NGG Thailand), the Association of Southeast Asian Nations (ASEAN) leaders in laboratory services and reproductive science, today announced the launch of VeriSeq™ NIPT Solution v2 in Thailand, a CE-IVD, next-generation sequencing (NGS)-based approach to noninvasive prenatal testing (NIPT).
The automated in-lab IVD solution will allow NGG Thailand to launch the Qualifi Prenatal Test and be the first laboratory in South East Asia to detect anomalies that targeted assays miss and deliver more insights into the health of a pregnancy compared to standard NIPT offerings. Using Illumina’s VeriSeq NIPT Solution v2, the test delivers a comprehensive view of the fetal genome compared to other CE-IVD NIPT products, enabling healthcare providers to support expectant parents with informed, timely and personalized pregnancy management options better than ever before.
“With expanded NIPT, healthcare providers can obtain a comprehensive view of all 23 chromosome pairs while limiting risk to their patient,” said Assoc. Prof. Boonsri Chanrachakul, M.D., Ph.D., OB/GYN specializing in Maternal Fetal Medicine, Bangkok, Thailand. “This technique will offer the accurate, sensitive, and specific screening for chromosomal changes and provide more information to healthcare providers and expectant parents to empower their journey through pregnancy.”
While conventional prenatal screening has been available for over 30 years, these tests were limited in their ability to screen beyond aneuploidies of chromosomes 21, 18, and 13. NGG Thailand’s Qualifi Prenatal Test uses VeriSeq NIPT Solution v2 to provide accurate information about fetal chromosomal status as early as 10 weeks of gestation using a single maternal blood draw. This noninvasive test provides a whole-genome sequencing (WGS) approach to NIPT, expanding prenatal screening beyond the three most common aneuploidies of chromosomes 21, 18 and 13, to all rare autosomal aneuploidies (RAAs), sex chromosome aneuploidies (SCAs), and large partial duplications and deletions.
Illumina Vice President and General Manager of Asia Pacific and Japan, Ms Gretchen Weightman, explained that the availability of VeriSeq NIPT Solution v2 is a key milestone in the partnership between Illumina and NGG Thailand.
“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,” Ms Weightman said.
The CE-IVD VeriSeq NIPT Solution v2 is now registered for use in Thailand, Vietnam, Singapore, South Korea, Australia, New Zealand, Israel, South Africa and across most countries in Europe.
The clinical accuracy of the CE-IVD VeriSeq NIPT Solution v2, with respect to outcomes determined by a clinical reference standard assessment, was demonstrated by evaluating more than 2,300 plasma samples from pregnant women with singleton and twin pregnancies undergoing prenatal screening for fetal chromosome aneuploidies and partial deletions and duplications of 7 Mb or greater. The study determined that VeriSeq NIPT Solution v2 provided highly sensitive and specific results – 98.8 percent passed assay quality control on the first pass.