A wish to advance ISH

TUCSON, Ariz.—Ventana Medical Systems Inc., a member of theRoche Group, and Hayward, Calif.-based Advanced Cell Diagnostics Inc. (ACD) inmid-December inked a worldwide co-promotion agreement for what they say will bethe first commercially available, fully automated RNA in-situ hybridization (ISH) assay system capable of "robustdetection and visualization of virtually any expressed gene in routine clinicalspecimens at single-molecule sensitivity."

Moreover, the companies maintain that the RNAscopeformalin-fixed paraffin-embedded (FFPE) reagent systems automated on theVentana DISCOVERY ULTRA and DISCOVERY XT will offer researchers "a powerfultool with unprecedented levels of performance," particularly for ISHapplications.

Specifically, the companies will be automating the assaysystem on the Ventana DISCOVERY series of slide-staining platforms. The productofferings are expected to become commercially available in the first quarter of2012 and will initially be offered for research-use only applications, which isfitting considering that the RNAscope products aren't intended for diagnosticapplications, nor are any of the DISCOVERY products.

"Given the fact that the majority of biomarkers arediscovered from genomic research and are RNA by nature, the automation ofRNAscope represents an important milestone that will accelerate biomarkerresearch 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 equallyindispensable tool alongside immunohistochemistry, fluorescence in-situ hybridization and polymerase chain reaction forresearchers in life sciences and drug development," and adds that the abilityto generate robust and reproducible results from routine clinical specimens"makes the technology a compelling platform for clinical diagnosticapplications in the foreseeable future."

In the news release about the deal, the companies callRNA-based ISH "an indispensable method to analyze gene expression in thecontext of tissue architecture in areas of oncology, virology and neuroscienceresearch." They note that RNAscope is an award-winning, breakthrough technologythat provides researchers the unique capability to interrogate the function anddisease relevance of any expressed genes in situ, especially for the approximately 5,000 genes and 15,000 non-codingRNAs in the human genome that no other technologies can adequately address. Inaddition, RNAscope allows researchers to tap into the estimated 400 millionclinically annotated, archived FFPE tissue specimens for retrospective clinicalstudies in translational research.

"The combination of RNAscope reagent system and oursophisticated and flexible DISCOVERY platform and detection systems delivers apowerful solution for biomarker discovery and validation," said Bill Crawford,Ventana's director of marketing for the company's Discovery division, in anofficial statement. "It has significant potential to advance cell- andtissue-based biomarker analyses for future clinical and companion diagnosticsdevelopment."

News of the Ventana-ACD deal came just a little more than amonth after ACD announced that it had received the 2011 North American Frost& Sullivan Technology Innovation Award for its RNAscope platform, based onFrost & Sullivan's recent analysis of the in-situ biomarker detection assay market.

"RNAscope provides the first opportunity to profile singlecell gene expression in situ, leveraging the full potential of RNA biomarkertechnology," said Cecilia Van Cauwenberghe, a Frost & Sullivan seniorresearch analyst, at the time. "This technology offers unique opportunities bytargeting the molecular signature of every cell within the intricate cellularstructure and tissue architecture evidenced in clinical specimens."

Furthermore, the RNAscope technology platform excels overconventional assays by reaching significantly high levels of specificity andsensitivity in detecting virtually any gene in the human transcriptome insitu, while simultaneously enablingquantification of multiple mRNA transcripts at a single-cell level.

"Other strengths include quantitative analysis, enabling thedetection of each target to be quantified on a per-cell basis," noted VanCauwenberghe. "In addition, it offers colorimetric or fluorescent readout underbright field or fluorescent microscope, broad sample type spectrum, as well asspeed and throughput compatibility with fully automated walk-away assaysystems. The technology has been demonstrated to achieve RT-PCR-levelsensitivity and specificity. RNAscope is viewed as being over 100-fold moresensitive than traditional non-isotopic ISH methods."