Advanced Cell Diagnostics receives ISO certification for RNAscope production

Advanced Cell Diagnostics has announced that it has been granted ISO 13485:2003 certification, an international quality standard for medical devices.

Awarded by the International Organisation for Standardisation, the certification covers the design, development, production and commercialisation of the company's proprietary RNAscope product lines, paving the way for their European launch.

The RNAscope portfolio has seen rapid adoption by academic and industrial researchers alike since the global rollout of the products commenced in 2011. The technology represents the first automated multiplex RNA in situ hybridisation platform that can detect and quantify biomarkers with single?molecule sensitivity.

Industry interest in moving RNAscope-based biomarker assays from research to the clinic has been shown to be strong.

Dr Yuling Luo, president and chief executive officer of Advanced Cell Diagnostics, said: "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."

Based in Canada, the company has been operating since 1994 and currently employs more than 160 employees worldwide.