VeriSeq NIPT Analysis Software (16 Samples)

VeriSeq NIPT Analysis Software (16 Samples)

VeriSeq NIPT Analysis Software (16 Samples) provides clinical labs in the European Union (EU) with a fast, proven, CE-IVD marked solution for analyzing sequencing data for use in noninvasive prenatal testing (NIPT).

  • Easy-to-use, validated CE-IVD marked NIPT analysis software removes the burden of bioinformatics development
  • Proven, whole-genome sequencing (WGS)-based NIPT analysis method shown to minimize test failures1,2
  • Fast turnaround enables users to go from sequencing data to NIPT results in 2 hours on a secure, onsite server

In just 2 hours, VeriSeq NIPT Analysis Software analyzes WGS data for the presence of trisomy 13, trisomy 18, trisomy 21, and sex chromosome aneuploidies. Combining accessibility, accuracy, and speed, VeriSeq NIPT Analysis Software provides a ready-to-use, affordable data analysis solution that enables clinical labs to expand their current offerings to include NIPT.

VeriSeq Software filters and aligns WGS sequencing reads to a reference genome. It then uses a sophisticated counting-based algorithm to detect over- or underrepresented test chromosomes and provide a normalized chromosome value (NCV) for the test chromosome. Studies have shown that this approach minimizes test failures.1,2 Built-in quality assessment (QA) of each sample ensures confidence in the obtained results. Clinical labs perform their own clinical validation studies to establish guidelines for calling aneuploidy based on this output and provide results in their own report format.

VeriSeq NIPT Analysis Software runs on a dedicated VeriSeq NIPT Analysis Server. Data remains on site and accessible only over a private network. There’s no need to send out data for analysis, saving time and protecting sample identity.

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References
  1. Data on file. Illumina, Inc. 2015.
  2. Taneja PA, Snyder HL, de Feo E, et al. Noninvasive prenatal testing in the general obstetric population: clinical performance and counseling considerations in over 85 000 cases. Prenat. Diagn. 2015;Dec 30. Doi: 10.1002/pd.4766. [Epub ahead of print].
Intended Use Statement

The VeriSeq NIPT Analysis Software (16 Samples) generates quantitative scores to aid in the detection and differentiation of fetal aneuploidy status for chromosomes 21, 18, 13, X, and Y by analyzing sequencing data generated from cell-free DNA (cfDNA) fragments isolated from maternal peripheral whole blood specimens in pregnant women of at least 10 weeks gestation. The quantitative scores are z-scores associated with under- or over-representation of a target chromosome relative to an expectation for a diploid genome.