Quantitative biomarker analysis advanced by alliance between Advanced Cell Diagnostics and Definiens, providers of breakthrough platform for in situ RNA biomarker detection and leading image analysis technology for digital pathology

Definiens and Advanced Cell Diagnostics (ACD) today unveiled the details of the RNAscope SpotStudio image analysis software to attendees at the Molecular Medicine Tri-Conference meeting in San Francisco, USA. The software has already been sold to a top pharmaceutical company and a leading academic medical center under an early access program. This advanced image analysis solution brings objective and accurate quantification to RNA in situ hybridization and enables a new generation of diagnostic applications based on single cell analysis. For the first time, gene expression can be measured quantitatively at single-cell resolution and interpreted by pathologists within histopathological context.

Empowering Pathologists with an Easy-to-Use Tool for Quantitative Biomarker Analysis

Quantitative RNA in situ hybridization analysis has recently been made possible by the single molecule sensitivity and digital nature of RNAscope® assay technology. However, manual scoring is time consuming and prone to subjectivity and poor reproducibility. RNAscope SpotStudio software is designed for pathologists with no prior training in image analysis. It is an intuitive automated solution that generates standardized and objective results in minutes. Testing has shown that results obtained with RNAscope SpotStudio are comparable to careful manual annotations by pathologists. The software is compatible with image data from whole slide scanners and microscopes.

“In situ biomarker analysis tools such as immunohistochemistry (IHC) have been limited to subjective semi-quantitative scoring. RNAscope and the SpotStudio image analysis software take in situ biomarker analysis to a whole new level, where quantitative data at the single cell level can be obtained and interpreted within the histopathological context of the clinical specimen”, said Yuling Luo, Founder, President and CEO of ACD. “RNAscope combines the advantages of IHC and PCR, making it a superior tool for tissue-based diagnostics and companion diagnostics”, Dr. Luo added. “Definiens’ invaluable expertise with tissue image analysis made it an ideal partner for the joint development of RNAscope SpotStudio.”

“Coming from a leading position in providing image analysis solutions to the life sciences market, Definiens is rapidly expanding its footprint in tissue diagnostics. We are very excited about this partnership with ACD representing a great example of advanced diagnostic solutions based on Definiens image and data analysis capabilities that will drive next generation diagnostics to truly enable personalized medicine”, said Thomas Heydler, CEO of Definiens.

Definiens and ACD will showcase RNAscope SpotStudio at the Molecular-Med Tri-Con in San Francisco (booth 210). The solution will be marketed and distributed by ACD and is currently being distributed to selected customers in an early access program. General availability is planned for the second quarter of 2013.

While RNAscope Spot Studio supports the analysis of brightfield images, RNA FISH assays can be quantified with Definiens Tissue Studio®. With over 450 deployed licenses, Definiens Tissue Studio is the leading image analysis solution for digital pathology. Beyond the detection of spot-like stains, Definiens Tissue Studio provides morphological and molecular expression profiles from any solid tissue (IHC and IF) on a cell-by-cell basis.

About Definiens

Definiens is the leading provider of image analysis and data mining solutions for life sciences, tissue diagnostics and clinical digital pathology. Definiens software provides detailed cell-by-cell readouts from target structures on whole tissue slides, and allows the correlation of this information with data derived from other sources. By automating analysis workflows, Definiens helps pharmaceutical and biotechnology companies, research institutions, clinical service organizations and pathologists to generate new knowledge and support better decisions in research, diagnostics and therapy. Definiens’ vision is to open new fields of research, to contribute to development of personalized medicine and to significantly improve the quality of patients’ lives.

Definiens is headquartered in Munich, Germany and has offices throughout the United States.

Further information is available at www.definiens.com.

About Advanced Cell Diagnostics

Advanced Cell Diagnostics, Inc. (ACD) is a leader in the emerging field of molecular pathology, developing cell- and tissue-based research tools for all areas of biomedical research, and diagnostic tests for personalized medicine. The company’s products and services are based on its proprietary RNAscope® technology, the most sensitive method available for RNA ISH, and the first quantitative and fully automated platform enabling multiplex fluorescent and chromogenic RNA biomarker analysis. ACD partners with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapeutic development in cancer and other diseases. These partnerships provide the foundation for ACD to develop companion diagnostic tests in conjunction with partners’ targeted therapeutics. ACD also pursues internal programs to develop proprietary diagnostic tests in cancer management.

Learn more about ACD and RNAscope technology at www.acdbio.com