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Enhanced assay robustness heralds a new era for tissue-based RNA biomarker development

Advanced Cell Diagnostics Inc. (ACD), the market leader in tissue-based RNA analysis tools for molecular pathology, has announced the release of its next version RNAscope^® in situ hybridization (ISH) assay – RNAscope 2.5.

The current RNAscope 2.0 assay has been gaining recognition rapidly in the research community, as indicated by its use in over 300 peer-reviewed publications within 4 years. More than ever, the translation of genomic discoveries to clinical applications demands high performance, ease of use and broad accessibility. Building on the groundbreaking advances introduced in RNAscope 2.0, the 2.5 assay incorporates many refinements and enhancements to enable rapid, accurate assessment of tissue-based biomarker expression across the full spectrum of clinical formalin-fixed paraffin-embedded (FFPE) tissue samples at unprecedented levels of consistency and reproducibility without the need for lengthy rounds of assay optimization.

Excellent results have already been achieved with RNAscope 2.5 in an early access program, as Victoria Rimkunas, Head of the Integrated Diagnostics Lab at Merrimack Pharmaceuticals, Inc., summarized: “We are using RNAscope technology in the development of our companion diagnostics assay pipeline. We participated in ACD’s early access program to evaluate RNAscope 2.5 on Leica Biosystems’ BOND Rx system, and are very pleased with the results. We obtained strong sensitive detection with punctate dots and clean to no background, enabling easy identification of true signal without interference. We evaluated assay robustness across multiple tissue types and observed reproducibility across sites. We are happy to move forward with RNAscope 2.5 and plan to use this assay and technology in future clinical studies.”

Dr. Yuling Luo, Founder, President and CEO of ACD, added: “I believe RNAscope 2.5 ushers in a new exciting era for scientists seeking to develop tissue-based biomarkers, especially for companion diagnostics. The many refinements and innovations we’ve made in 2.5 add up to make a major difference in terms of robustness and reproducibility. It is now a diagnostic grade product. Our customers working on the cutting edge of translational research and companion diagnostic development now have a seamless path to the clinic – they can use the same platform for both research and diagnostics with no translation needed. We are very excited about that.”

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