CE-IVD marked software utilizes paired-end sequencing data for
clinical labs in the EU
SAN DIEGO--(BUSINESS WIRE)--Jan. 30, 2017--
Illumina, Inc. (NASDAQ: ILMN) today announced that it has declared
conformity with the requirements of the IVD Directive and has applied
the CE mark to an expanded VeriSeq™ NIPT Analysis Software for clinical
laboratories in the European Union (EU). This updated VeriSeq™ NIPT
Analysis Software includes an innovative method for processing samples
and is designed for larger batches of 48 samples, versus the current 16
samples, which can scale to meet the future demands of the growing
noninvasive prenatal testing (NIPT) market. Using this software,
clinical labs in the EU have access to fast and reliable software for
analysis of sequencing data for NIPT.
The CE marking signifies that the analysis software complies with the
quality standards set by the European In Vitro Diagnostics
Directive (98/79/EC), and certifies that it has been created and
manufactured to meet strict safety and health criteria for distribution
in the EU. This new software introduces a method that utilizes
paired-end sequencing data.
“The update to the VeriSeq™ NIPT Analysis Software is another important
milestone towards providing a more complete high-quality NIPT solution
to our laboratory partners in the EU,” said Jeff Hawkins, Vice President
and General Manager of Reproductive and Genetic Health at Illumina.
“With this software, Illumina is enabling more clinical laboratories to
implement NIPT testing efficiently and affordably in-house, increasing
overall workflow efficiency and reducing the costs of testing.”
The VeriSeq™ NIPT Analysis Software 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 fragments isolated from maternal peripheral whole
blood specimens in pregnant women of at least 10 weeks gestation.
The release of the VeriSeq™ NIPT Analysis Software (48 Samples)
represents an important step toward Illumina’s plan to provide a full
CE-IVD NIPT solution. The upcoming VeriSeq™ NIPT Solution will include
CE-IVD marked assay specific reagents with a supporting clinical
About Illumina, Inc.
Illumina is improving human health by unlocking the power of the genome.
Our focus on innovation has established us as the global leader in DNA
sequencing and array-based technologies, serving customers in the
research, clinical, and applied markets. Our products are used for
applications in the life sciences, oncology, reproductive health,
agriculture, and other emerging segments. To learn more, visit www.illumina.com and
This release contains forward-looking statements that involve risks and
uncertainties. Examples of forward-looking statements include, but are
not limited to, statements we make regarding the expected availability
dates for new products and services and FDA submission dates and
intentions for certain products and services. Important factors that
could cause actual results to differ materially from those in any
forward-looking statements include challenges inherent in developing,
manufacturing, and launching new products and services, and the other
factors that are detailed in our filings with the Securities and
Exchange Commission, including our most recent filings on Forms 10-K and
10-Q, or in information disclosed in public conference calls, the date
and time of which are released beforehand. We do not intend to update
any forward-looking statements after the date of this release.
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Source: Illumina, Inc.