NEW YORK (GenomeWeb) – Illumina said on Monday that it has received regulatory clearance for its MiSeqDx system from the China National Drug Administration, enabling it to sell the system in China for diagnostic testing.
"The clearance of the MiSeqDx in China is a significant milestone for Illumina because it provides more opportunities for NGS," Garret Hampton, executive vice president of clinical genomics at Illumina, said in a statement. "More medical institutions and patients will now have access to the latest NGS technology."
Previously, Illumina partnered with Berry Genomics to garner regulatory clearance for a noninvasive prenatal test to be run on a version of Illumina's NextSeq instrument developed specifically for diagnostic use in China.
The approval of the MiSeqDx instrument, by contrast, was not tied to a specific assay. Illumina said it can now market and sell the system to hospitals and other medical institutions for in vitro diagnostic testing throughout China.