Advanced Cell Diagnostics Receives ISO 13485:2003 Certification

August 11, 2014

RNAscope(R) Technology Poised for Development as a Diagnostic Platform

HAYWARD, California, August 11, 2014 /PRNewswire/ –

Advanced Cell Diagnostics, Inc [http://www.acdbio.com ]. (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(R) 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.

For further information, please visit http://www.acdbio.com.

SOURCE Advanced Cell Diagnostics Inc. (ACD)

Source: PR Newswire

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