Illumina 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."
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.