NEW YORK (GenomeWeb News) – NanoString Technologies today said that it has received ISO 13485:2003 certification for its nCounter Analysis System, which includes its multiplex molecular detection instrument and reagents.
The certification, from the International Organization for Standardization, covers the design, development, production, sales, and service of the nCounter system. The certificate was awarded by G-MED North America, a subsidiary of LNE.
"Our international customer base can be assured that the products we deliver today are of the highest standards, and that the ISO 13485:2003 criteria will provide a quality foundation upon which we and our partners will develop new diagnostic products," Mary Tedd Allen, VP of manufacturing for NanoString, said in a statement.
NanoString's nCounter is built upon technology licensed exclusively from the Institute for Systems Biology and uses digital barcoding to enable multiplexed, direct profiling of individual molecules in a single reaction without amplification. The first application for the system is in gene expression, but the company is also working on other tasks like copy number assays and microRNA analysis.
The firm hopes the system will eventually be used in clinical diagnostic applications.