The assay profiles single cell gene expression in situ, unlocking the full potential of RNA biomarkers. The targeted molecular signature of every cell in a sample is revealed and measured precisely, all within the intricate cellular and tissue architecture of clinical specimens. The in situ assay has single molecule sensitivity and it can be completed in six hours.

The kit, known as the RNAscope FFPE Assay Kit, demonstrated polymerase chain reaction (PCR)-level sensitivity and specificity, detecting an RNA biomarker in all samples deemed positive by real time reverse transcriptase PCR, but not in samples deemed negative. In contrast, using a traditional nonisotopic in situ hybridization (ISH), the biomarker was only detected in the highest expressing sample. Since the PCR-positive samples showed two orders of magnitude difference in expression levels, RNAscope is as much as 100-fold more sensitive than the traditional nonisotopic ISH method. It does not require any expensive instrument and the staining results can be stored as archival and can be visualized and interpreted under a bright field microscope.

RNAscope is manufactured by Advanced Cell Diagnostics, Inc (Hayward, CA, USA). The products are intended to be used by translational clinical scientists studying biomarkers in disease tissues and exploring their potential for diagnostic applications. Yuling Luo, Ph.D., President and CEO of the company, said, "Over the last several decades, immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) technologies have been developed to detect proteins and DNA in situ, respectively. But reliable detection of RNA in situ remains difficult, especially in routine clinical specimens. The scientific community is being offered an 'IHC-like' tool for RNA that has the sensitivity and specificity rivaling that of PCR."

RNAscope multiplex technology has the sensitivity to detect every gene in the human transcriptome in situ, and to quantify simultaneously multiple mRNA transcripts at a single cell level. While RNAscope is designated as research use only product at the moment, the company is developing fully automated, proprietary diagnostic tests for personalized cancer treatment. The company is also partnering with pharmaceutical and biotechnology companies to leverage its RNAscope platform for companion diagnostic applications.

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