Market Overview

Illumina Receives Approval of MiSeq™Dx System in China

Share:

Enabling Growing Genomic Applications in Chinese Clinical Market

Illumina,
Inc.
(NASDAQ:ILMN) today announced that its MiSeq™Dx
Sequencing System
received the approval certificate from the China
National Drug Administration (CNDA). This is Illumina's first
CNDA-cleared, next-generation sequencing (NGS) system in China. In
accordance with the clearance, Illumina can now market and sell the
MiSeqDx Sequencing System to hospitals and other medical institutions
for in-vitro diagnostic (IVD) testing throughout China.

Designed specifically for the clinical laboratory environment, the
MiSeqDx Sequencing System is a benchtop sequencer that incorporates an
easy-to-use workflow and data output tailored to the diverse needs of
clinical labs. Taking advantage of proven Illumina sequencing by
synthesis (SBS) chemistry, the MiSeqDx Sequencing System provides IVD
developers the tools to create accurate diagnostic testing.
Additionally, integrated software enables run setup, sample tracking,
user management, audit trails and data interpretation.

"The clearance of the MiSeqDx in China is a significant milestone for
Illumina because it provides more opportunities for NGS," said Garret
Hampton, Executive Vice President of Clinical Genomics at Illumina.
"More medical institutions and patients will now have access to the
latest NGS technology. We are encouraging more clinical companies to
select the MiSeqDx System to develop new clinical assays and to help
provide needed solutions to some of China's greatest health challenges."

The MiSeqDx Sequencing System now has regulatory approval in the United
States, China, Canada, Argentina, European countries recognizing the
CE-IVD mark, Australia, South Korea, Singapore, Thailand and the
Philippines.

For more information on the MiSeqDx Sequencing System, please visit www.illumina.com/miseqdx.

About Illumina

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.

Use of forward-looking statements

This release contains forward-looking statements that involve risks and
uncertainties. These forward-looking statements are based on our
expectations as of the date of this release and may differ materially
from actual future events or results. Among the important factors that
could cause actual results to differ materially from those in any
forward-looking statements are (i) our ability to further develop and
commercialize our instruments and consumables, including our diagnostic
kit products, and to deploy new products such as the MiSeq™Dx System,
services and applications, and expand the markets for our technology
platforms; (ii) our ability to manufacture robust instrumentation and
consumables; (iii) our ability to successfully identify and integrate
acquired technologies, products or businesses; (iv) the future conduct
and growth of the business and the markets in which we operate; and (v)
challenges inherent in developing, manufacturing, and launching new
products and services, together with other factors 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 undertake no obligation, and do not intend, to update
these forward-looking statements, to review or confirm analysts'
expectations, or to provide interim reports or updates on the progress
of the current quarter.

View Comments and Join the Discussion!