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Definiens and Advanced Cell Diagnostics Launch Software for Quantitative RNA In Situ Hybridization

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Definiens AG, a healthcare company that advances personalized medicine through image analysis and digital pathology solutions, and Advanced Cell Diagnostics (ACD) of Hayward California, a leader in molecular pathology, announced recently the commercial launch of RNAscope® SpotStudio™, a custom-designed image analysis software application for ACD’s RNAscope®Assays to detect and quantify RNA biomarkers. By combining state-of-the-art image analysis and advanced in situ hybridization technologies, gene expression can be measured quantitatively at single cell resolution and interpreted by pathologists within context.

Historically, manual scoring of tissue biomarkers and phenotypes has been time consuming, prone to subjectivity, and poor reproducibility. RNAscope® SpotStudio™ Software is designed to be intuitive for pathologists and life science researchers to use and generate standardized and objective results in minutes, and is compatible for use with whole slide scanners and microscopes. In a recent publication featured in the Journal of Molecular Diagnostics (3/15/2013; http://www.ncbi.nlm.nih.gov/pubmed/23305906), a team led by Dr. Raymond Tubbs at Cleveland Clinic applied this novel approach to determine HER2 status in breast cancer patients and compared it with conventional testing methods such as FISH, IHC and qRT-PCR. The results demonstrated 97% concordance between quantitative RNAscope and FISH. SpotStudio-based single-cell level quantification of HER2 mRNA demonstrated strong correlation with qRT-PCR (Pearson r = 0.84) and was superior to qRT-PCR in resolving equivocal or heterogeneous HER2 status.

“The combination of RNAscope® with SpotStudio™ Image Analysis Software is extremely powerful for advancing the biomarker research and diagnostics,” said Thomas Heydler, CEO of Definiens. “We believe that while genome studies have started the revolution in healthcare, personalized medicine will distinctly depend on advanced diagnostics at the tissue and cellular level. This partnership is a demonstration of the future of in situ biomarker analysis–a breakthrough single cell RNA assay plus a powerful image analysis solution to extract the results.”

“Combining the advantages of IHC and PCR, it is a breakthrough technology for tissue based biomarker studies and companion diagnostics. By partnering with Definiens, we are able to commercialize a truly revolutionary solution. For the first time, researchers can detect and quantify RNA in individual cells of interest in heterogeneous tissues to better understand the biology of particular genes and cells,” said Yuling Luo, Founder, President, and CEO of ACD.

Source: Business Wire