Advanced Cell Diagnostics (ACD) has launched RNAscope FFPE Assay Kit, a line of RUO (Research-Use-Only) products designed to detect RNA biomarkers in formalin-fixed, paraffin-embedded (FFPE) tissue specimens with single molecule sensitivity.
ACD said that the RUO products are intended to be used by translational clinical researchers studying biomarkers in disease tissues and exploring the potential for diagnostic applications.
The RNAscope FFPE is a 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.
The RNAscope FFPE assay, in collaborative blind study with a pharmaceutical company, demonstrated PCR-level sensitivity and specificity, detecting an RNA biomarker in all samples deemed positive by real time RT-PCR.
ACD claimed that as 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 has been developing fully automated 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.
Yuling Luo, founder, president and CEO of ACD, said: “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. The scientific community has finally got an ‘IHC-like’ tool for RNA that has the sensitivity and specificity rivaling that of PCR.”