Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
RANDOX LABORATORIES

RNA Biomarker Assay Now Manufactured According to Strict ISO Regulatory Criteria

By Labmedica International staff writers
Posted on 19 Aug 2014
Print article
Image: RNAscope detects TP63 mRNA expression in human prostate tissue (Photo courtesy of Advanced Cell Diagnostics).
Image: RNAscope detects TP63 mRNA expression in human prostate tissue (Photo courtesy of Advanced Cell Diagnostics).
A line of diagnostic kits that measures RNA biomarkers with single-molecule sensitivity is now being manufactured under the stringent requirements of ISO 13485:2003 certification.

Advanced Cell Diagnostics, Inc. (Hayward, CA, USA), a global technology and market leader in in situ nucleic acid detection for life science research and clinical diagnostics, announced that the production facility for its line of RNAscope assays has received ISO 13485:2003 certification. ISO 13485:2003 certification, issued by the International Organization for Standardization (Geneva, Switzerland), the world's largest developer and publisher of international standards, regulates design, development, production, and commercialization for the implementation of quality management systems and various other technical and operational procedures.

Radioscope technology is the first automated multiplex RNA in situ hybridization platform capable of detecting and quantifying RNA biomarkers with single-molecule sensitivity. RNA expression levels are highly dynamic and integrate both genetic and epigenetic mechanisms of gene regulation. Thus, RNA expression reflects the state of a biological system. Measuring RNA biomarkers as RNA provides the most direct route for biomarker validation and assay development.

RNAscope employs a proven design strategy similar to fluorescence resonance energy transfer (FRET), in which two independent probes (double Z probes) must hybridize to the target sequence in tandem in order for signal amplification to occur. Because it is highly unlikely that two independent probes will hybridize to a nonspecific target right next to each other, this design concept ensures selective amplification of target-specific signals. For each target RNA species, 20 double Z target probe pairs are designed to specifically hybridize to the target molecule, but not to nontargeted molecules.

"Advanced Cell Diagnostics' vision is to make RNAscope the PCR equivalent for in situ nucleic acid detection and drive adoption of this technology in diagnostic tests," said Dr.Yuling Luo, president and CEO of Advanced Cell Diagnostics. "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."

Related Links:

Advanced Cell Diagnostics, Inc.
International Organization for Standardization



Print article

Channels

Genetic Tests

view channel

Patterns of MicroRNA Expression Distinguish Patients with Asthma and Allergic Rhinitis

Subsets of circulating micro RNAs (miRNAs) are uniquely expressed in asthmatic patients and in patients with allergic rhinitis (AR) and have potential for use as noninvasive biomarkers to diagnose and characterize these diseases. MicroRNAs are a class of about 20 nucleotides-long RNA fragments that block gene expression... Read more

Pathology

view channel

Liver Cancer May Be Diagnosed from Altered Sugar Metabolism

Altered gene expression that causes cancerous cells to metabolize fructose differently from healthy cells could be a significant new biomarker for diagnosing liver cancer. Dietary fructose is primarily metabolized in the liver and it has now been demonstrated that, compared with normal hepatocytes, hepatocellular carcinoma... Read more

Industry News

view channel

R-Biopharm and Merck Partner on Companion Diagnostics

R-Biopharm AG (Darmstadt, Germany) and Merck KGaA (Darmstadt, Germany) have entered into an agreement that constitutes their first collaboration, which will initially focus on developing and launching companion diagnostics. Companion diagnostics play a central role in personalized medicine by helping to find specific... Read more
Copyright © 2000-2016 Globetech Media. All rights reserved.