Illumina Debuts VeriSeq™ Analysis Software (48 Samples), Optimized Data Analysis for Noninvasive Prenatal Testing
January 30 2017 - 2:00AM
Business Wire
CE-IVD marked software utilizes paired-end
sequencing data for clinical labs in the EU
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 accuracy study.
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
follow @illumina.
Forward-Looking Statements
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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