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Frost & Sullivan Lauds Advanced Cell Diagnostics for Its Highly Innovative In Situ Biomarker Detection Assay Kit

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Based on its recent analysis of the in situ biomarker detection assay market, Frost & Sullivan recognizes Advanced Cell Diagnostics, Inc. with the 2011 North American Frost & Sullivan Technology Innovation Award for its RNAscope platform.

Advanced Cell Diagnostics’ RNAscope formalin-fixed and paraffin-embedded (FFPE) Assay Kit, a novel multiplex nucleic acid in situ hybridization technology, is based on a proprietary and unique probe design and signal amplification methodology. It is designed to detect RNA biomarkers in routine FFPE tissue specimens with single molecule sensitivity and at single cell resolution.

“RNAscope provides the first opportunity to profile single cell gene expression in situ, leveraging the full potential of RNA biomarker technology,” said Frost & Sullivan Senior Research Analyst Cecilia Van Cauwenberghe. “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. This constitutes a paradigm shift in molecular pathology and represents a breakthrough in personalized medicine.

RNAscope offers end-users an enhanced toolset for research and development applications and their further translation to clinical diagnostics. Among its advantages are rapid assay development; ultimate sensitivity, including single molecule detection in situ; high specificity, allowing the distinguishing of highly homologous genes; and multiplexing capability through the simultaneous detection of multiple targets.

“Other strengths include quantitative analysis, enabling the detection of each target to be quantified on a per cell basis,” said Cecilia 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.”

RNAscope offers end-users high levels of flexibility and customization capabilities that adapt and evolve with the drug discovery and development process, significantly contributing to the acceleration of biomarker validation.

“The technology has been demonstrated to achieve RT-PCR-level sensitivity and specificity,” said Cecilia Van Cauwenberghe. “RNAscope is viewed as being over 100-fold more sensitive than traditional non-isotopic ISH methods.”

In the near future, RNAscope can be deployed by pathologists as part of their laboratory routine for molecular diagnostics. According to a recent clinical study utilizing RNAscope technology to detect human papillomavirus (HPV) E6/E7 mRNA in routine clinical specimens of head and neck cancer, the HPV status determined by the RNAscope HPV test was highly predictive of patient outcome. It revealed high concordance to a surrogate protein marker and much higher sensitivity than an existing DNA-based test.

In recognition of these features, Frost & Sullivan is proud to present Advanced Cell Diagnostics, Inc. with the 2011 Technology Innovation Award in the North American in situ biomarker detection assay market. Each year, Frost & Sullivan presents this award to the company that demonstrates uniqueness in developing a technology, which significantly impacts both the functionality and the customer value of new products and applications. The award lauds the relevance of the innovation to the industry.

Frost & Sullivan’s Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis and extensive secondary research to identify best practices in the industry.

Source: Marketwire