ACD launches RNAscope Formalin-Fixed, Paraffin-Embedded Assay Kit

Advanced Cell Diagnostics, Inc. (ACD), announces the launch and immediate availability of RNAscope™ FFPE Assay Kit, a line of RUO (Research-Use-Only) products designed to detect RNA biomarkers in routine Formalin-Fixed, Paraffin-Embedded (FFPE) tissue specimens with single molecule sensitivity.

The products are intended to be used by translational clinical researchers studying biomarkers in disease tissues and exploring their potential for diagnostic applications. It is a robust and standardized manual assay in ready-to-use format that can be completed in approximately 6 hours. It does not require any expensive instrument and the staining results are archivable and can be visualized and interpreted under a bright field microscope. Unlike the earlier version of the assay, this clinical-grade assay can be transitioned seamlessly from translational research into clinical diagnostics. "Over the last several decades, IHC and 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," said Dr. Yuling Luo, Founder, President and CEO of ACD. "The scientific community has finally got an 'IHC-like' tool for RNA that has the sensitivity and specificity rivaling that of PCR."

In a blind test in collaboration with a leading pharmaceutical company, the RNAscope™ FFPE assay demonstrated PCR-level sensitivity and specificity, detecting an RNA biomarker in all samples deemed positive by real time RT-PCR but not in samples deemed negative. In contrast, using a traditional non-isotopic ISH, the collaborator detected the biomarker only 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 non-isotopic ISH method.

In addition to its RUO line of products, ACD 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.