Illumina Registers MiSeqDx System in South Korea
May 09 2016 - 04:05PM
Business Wire
Regulatory milestone clears path for clinical
laboratories to use Illumina NGS technology
Illumina, Inc. (NASDAQ: ILMN) today announced it has received a
product approval certificate for the MiSeqDx® Instrument and the
MiSeqDx Universal Kit with the Ministry of Food and Drug Safety
(MFDS) in South Korea. This successful approval of an Illumina
next-generation sequencing (NGS) system is the first step in
completing a comprehensive regulatory strategy in the APAC
region.
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Illumina's MiSeqDx System for
next-generation sequencing (Photo: Business Wire)
“This is an exciting milestone for the clinical market in South
Korea,” said Tim Orpin, Vice President and General Manager for
Illumina in the Asia Pacific region. “The MiSeqDx technology
enables clinicians to obtain comprehensive and reliable results
from NGS-based genetic tests.”
The MiSeqDx Instrument offers users the ability to perform NGS
for diagnostic or research applications on a single, easy-to-use
system. Designed and validated for the clinical market, the
instrument harnesses Illumina’s industry-leading sequencing by
synthesis (SBS) chemistry giving laboratories high confidence in
their results.
“Illumina is thrilled to receive this regulatory approval,”
added Jason Kang, Commercial Leader of Illumina Korea. “This
registration permits Illumina to supply clinical laboratories in
South Korea with our NGS technology. It will also accelerate the
process for us to get other Illumina clinical products into this
market in the future.”
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.
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Illumina, Inc.Investors:Rebecca Chambers,
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