ACD Receives ISO Certification
News Aug 12, 2014
Advanced Cell Diagnostics, Inc. (ACD) 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.
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.
Mechanism Controlling Multiple Sclerosis Risk IdentifiedNews
Researchers at Karolinska Institutet have now discovered a new mechanism of a major risk gene for multiple sclerosis (MS) that triggers disease through so-called epigenetic regulation. They also found a protective genetic variant that reduces the risk for MS through the same mechanism.
Antarctic Worm and Machine Learning Help Identify Cerebral Palsy EarlierNews
A research team has released a study in the peer-reviewed journal BMC Bioinformatics showing that DNA methylation patterns in circulating blood cells can be used to help identify spastic cerebral palsy (CP) patients. The technique which makes use of machine learning, data science and even analysis of Antarctic worms, raises hopes for earlier targeted CP therapies.
Ancient Syphilis Genomes Decoded for First TimeNews
Researchers recovered three genomes of the bacterium Treponema pallidum from skeletal remains from colonial-era Mexico, and were able to distinguish the subspecies that causes syphilis from the subspecies that causes yaws. It was not previously thought possible to recover DNA from this bacterium from ancient samples.