NEW YORK (GenomeWeb News) – Affymetrix said after the close of the market Wednesday that its GeneChip System 3000Dx v.2 has been approved by China's State Food and Drug Administration for in vitro diagnostic use.
According to Affy, its system is the first microarray instrument system to get SFDA registration for array-based diagnostics. The system previously was cleared for diagnostics use in the US and Japan, and it has the CE Mark in Europe. It also is available in Canada, Singapore, Australia, India, and Saudi Arabia, the firm noted.
"This registration clearance is a significant accomplishment for Affymetrix and supports our global clinical strategy," Andy Last, executive VP of the genetic analysis and clinical applications business unit at Affymetrix, said in a statement. "It connects us more closely to physicians in China wanting to utilize clinically relevant genomic biomarkers that improve their patients' health and wellness."
Affy noted that there are more than 10 tests being developed on the platform that are in the pipeline for regulatory clearance. It also noted that two tests that run on the GeneChip system have been cleared for marketing in the US — Roche's AmpliChip CYP450 test and Pathwork Diagnostics' Tissue of Origin test.