Illumina Registers MiSeqDx System in South Korea

SAN DIEGO–(BUSINESS WIRE)–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.
“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.