NEW YORK (GenomeWeb) – Advanced Cell Diagnostics said today it has received ISO 13485:2003 certification, enabling it to launch its CE-marked RNAscope product lines in Europe.
The certification covers RNAscope's design, development, production, and commercialization, ACD said.
The Hayward, Calif.-based company launched the RNAscope products commercially in 2011 for use by academic and industrial researchers, and now aims to expand their market to include clinical use.
"ACD's vision is to make RNAscope the PCR equivalent for in situ nucleic acid detection and drive adoption of this technology in diagnostic tests," company President and CEO Yuling Luo said in a statement.