Illumina recently received product approval certification for the NextSeq 550Dx with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. This is the first in vitro diagnostic (IVD) registered instrument for Illumina Japan and ushers in a new era of clinical sequencing for the Japanese market.
This registration provides distribution of the NextSeq 550Dx as a Class I medical device in Japan, enabling a broader personalized medicine path for patients with the use of next generation sequencing (NGS). There are now more opportunities to develop IVD solutions in Japan and be involved in strategic collaborations with pharmaceutical companies.
With this registration, Illumina, the global leader in DNA sequencing and array-based technologies, now has a NGS product capable of covering a broad range of clinical applications to serve almost any clinical lab need for NGS-based, IVD products throughout Japan.
“We are excited to obtain another regulatory approval in the Asia Pacific (APAC) region,” said Gretchen Weightman, Vice President and General Manager for Illumina in APAC. “Continued expansion of our products in the clinical lab will further advance our understanding of genetics and the potential to change the practice of medicine and enable genomics-based healthcare.”