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A wish to advance ISH
February 2012
by Jeffrey Bouley  |  Email the author
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TUCSON, Ariz.Ventana Medical Systems Inc., a member of the Roche Group, and Hayward, Calif.-based Advanced Cell Diagnostics Inc. (ACD) in mid-December inked a worldwide co-promotion agreement for what they say will be the first commercially available, fully automated RNA in-situ hybridization (ISH) assay system capable of "robust detection and visualization of virtually any expressed gene in routine clinical specimens at single-molecule sensitivity."  
 
Moreover, the companies maintain that the RNAscope formalin-fixed paraffin-embedded (FFPE) reagent systems automated on the Ventana DISCOVERY ULTRA and DISCOVERY XT will offer researchers "a powerful tool with unprecedented levels of performance," particularly for ISH applications.  
 
Specifically, the companies will be automating the assay system on the Ventana DISCOVERY series of slide-staining platforms. The product offerings are expected to become commercially available in the first quarter of 2012 and will initially be offered for research-use only applications, which is fitting considering that the RNAscope products aren't intended for diagnostic applications, nor are any of the DISCOVERY products.
 
"Given the fact that the majority of biomarkers are discovered from genomic research and are RNA by nature, the automation of RNAscope represents an important milestone that will accelerate biomarker research into a new level of sophistication," according to Dr. Yuling Luo, founder, president and CEO of ACD.  
 
He further predicts that "RNAscope will become an equally indispensable tool alongside immunohistochemistry, fluorescence in-situ hybridization and polymerase chain reaction for researchers in life sciences and drug development," and adds that the ability to generate robust and reproducible results from routine clinical specimens "makes the technology a compelling platform for clinical diagnostic applications in the foreseeable future."  
 
In the news release about the deal, the companies call RNA-based ISH "an indispensable method to analyze gene expression in the context of tissue architecture in areas of oncology, virology and neuroscience research." They note that RNAscope is an award-winning, breakthrough technology that provides researchers the unique capability to interrogate the function and disease relevance of any expressed genes in situ, especially for the approximately 5,000 genes and 15,000 non-coding RNAs in the human genome that no other technologies can adequately address. In addition, RNAscope allows researchers to tap into the estimated 400 million clinically annotated, archived FFPE tissue specimens for retrospective clinical studies in translational research.  
 
"The combination of RNAscope reagent system and our sophisticated and flexible DISCOVERY platform and detection systems delivers a powerful solution for biomarker discovery and validation," said Bill Crawford, Ventana's director of marketing for the company's Discovery division, in an official statement. "It has significant potential to advance cell- and tissue-based biomarker analyses for future clinical and companion diagnostics development."  
 
News of the Ventana-ACD deal came just a little more than a month after ACD announced that it had received the 2011 North American Frost & Sullivan Technology Innovation Award for its RNAscope platform, based on Frost & Sullivan's recent analysis of the in-situ biomarker detection assay market.
 
"RNAscope provides the first opportunity to profile single cell gene expression in situ, leveraging the full potential of RNA biomarker technology," said Cecilia Van Cauwenberghe, a Frost & Sullivan senior research analyst, at the time. "This technology offers unique opportunities by targeting the molecular signature of every cell within the intricate cellular structure and tissue architecture evidenced in clinical specimens."  
 
Furthermore, the RNAscope technology platform excels over conventional assays by reaching significantly high levels of specificity and sensitivity in detecting virtually any gene in the human transcriptome in situ, while simultaneously enabling quantification of multiple mRNA transcripts at a single-cell level.
 
"Other strengths include quantitative analysis, enabling the detection of each target to be quantified on a per-cell basis," noted Van Cauwenberghe. "In addition, it offers colorimetric or fluorescent readout under bright field or fluorescent microscope, broad sample type spectrum, as well as speed and throughput compatibility with fully automated walk-away assay systems. The technology has been demonstrated to achieve RT-PCR-level sensitivity and specificity. RNAscope is viewed as being over 100-fold more sensitive than traditional non-isotopic ISH methods."

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