Advanced Cell Diagnostics, Inc. (ACD), a global technology and market leader in in situ nucleic acid detection for life science research and clinical diagnostics, has been granted ISO 13485:2003 certification, an international quality standard for medical devices, paving a path for ACD to launch its CE marked diagnostic tests in Europe.
The International Organization for Standardization (ISO) is the world's largest developer and publisher of international standards for the implementation of quality management systems and various other technical and operational procedures. ACD's ISO 13485:2003 certification covers the design, development, production, and commercialization of ACD's proprietary RNAscope® product lines. Addressing a long-standing technological gap in the analysis of RNA, RNAscope has seen rapid adoption by both academic and industrial researchers since the beginning of its full commercialization in 2011. There is strong interest in moving RNAscope-based biomarker assays from research to the clinic.
"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," states Dr. Yuling Luo, President and CEO of ACD. "This ISO certification is the first step in our quality systems road map, which is designed to ensure that we supply products of the highest quality to our customers and provide a seamless path for our partners to translate scientific advances to patient benefits."
ACD's RNAscope technology is the first automated multiplex RNA in situ hybridization platform capable of detecting and quantifying biomarkers with single‐molecule sensitivity. Unlike "grind‐and‐bind" assays such as RT‐PCR requiring RNA extraction from tissues, RNAscope detects and localizes single RNA molecules in individual cells in intact tissues, enabling simultaneous molecular and histopathological analysis. Unlike immunohistochemistry (IHC) which is often limited by lack of quality antibodies and inapplicable to the large emerging class of non‐coding RNAs, RNAscope assays can be developed and validated in two weeks for virtually any gene in any genome regardless of coding potential. RNAscope assays can be performed manually or fully automated using standard automated slide staining instruments for IHC and ISH, allowing seamless integration of RNAscope into current clinical laboratory workflows.