VeriSeq NIPT Solution v2

Comprehensive in-lab NIPT IVD solution including reagents, instruments, and software for accurate aneuploidy screening results in 26 hours.

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Overview

Veriseq NIPT v2 is a streamlined, accessible NIPT solution that provides clinicians with results they can trust. 

  • A simple, easy-to-use, automated IVD prenatal screening solution that easily integrates into your lab's current workflow and flexes with your lab's growing needs

  • ≥ 99.9% sensitivity and specificity for trisomy 21, 18, and 131

  • Fast workflow with minimal hands-on time, enabling sample to report in ~26 hours 

Comprehensive screening

Broad test menu expands prenatal screening beyond aneuploidies 21, 18, and 13 to all rare autosomal aneuploidies (RAAs), sex chromosome aneuploidies (SCAs) and partial duplications and deletions ≥ 7 Mb for all autosomes. As a result, VeriSeq NIPT v2 detects anomalies that targeted assays miss to deliver more insights into the health of a pregnancy. 

Integrated and flexible workflow

VeriSeq NIPT v2 offers a simple, scalable IVD solution that can analyze 24, 48, or 96 samples per run. Sample preparation is automated on the VeriSeq NIPT Microlab STAR system from Hamilton Robotics. 

Trusted and reliable results

VeriSeq NIPT v2 is an extensively validated NIPT with a low test failure rate (1.2%) and high concordance with clinical reference data. 1 

Intended use

The VeriSeq NIPT Solution v2 is an in vitro diagnostic test intended for use as a screening test for the detection of genome-wide fetal genetic anomalies from maternal peripheral whole blood specimens in pregnant women of at least 10 weeks gestation. VeriSeq NIPT Solution v2 uses whole-genome sequencing to detect partial duplications and deletions for all autosomes and aneuploidy status for all chromosomes. The test offers an option to request the reporting of sex chromosome aneuploidy (SCA). This product must not be used as the sole basis for diagnosis or other pregnancy management decisions. The VeriSeq NIPT Solution v2 includes: the VeriSeq NIPT Workflow Manager v2 for the VeriSeq NIPT Microlab STAR, the VeriSeq NIPT Sample Prep Kits, and the VeriSeq Onsite Server v2 with the VeriSeq NIPT Assay Software v2. The VeriSeq NIPT Solution v2 is intended to be used with a next-generation sequencer. 

 

For In Vitro Diagnostic Use 

Contact an Illumina representative for regional availability. 

Specifications

Required products

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FAQs

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VeriSeq NIPT Solution v2

Comprehensive in-lab NIPT IVD solution including reagents, instruments, and software for accurate aneuploidy screening results in 26 hours.

References

  1. Pertile MD, Flowers N, Vavrek D, et al. Performance of a paired-end sequencing-based noninvasive prenatal screening test in the detection of genome-wide fetal chromosomal anomalies. Clin Chem. 2021;67(9):1210-1219. doi:10.1093/clinchem/hvab067
  2. Bianchi DW, Platt LD, Goldberg JD, Abuhamad AZ, Sehnert AJ, Rava RP. Genome-wide fetal aneuploidy detection by maternal plasma DNA sequencing. Obstet Gynecol. 2012;119(5):890-901. doi:10.1097/AOG.0b013e31824fb482
  3. Bianchi DW, Parker RL, Wentworth J, et al. CARE Study Group: DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014;370:799-808. doi:10.1056/NEJMoa1311037

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