Advanced Cell Diagnostics, Inc. (ACD), a global technology and market leader in in situ nucleic acid detection for life science research and clinical diagnostics, has been awarded a two-year, $1.4 million grant from National Cancer Institute (NCI) under its SBIR Phase II Program.

ACD and its academic partner Cleveland Clinic will use the grant to develop and validate a diagnostic test based on ACD’s proprietary RNAscope^® technology for discriminating various B-cell non-Hodgkin lymphomas (NHLs) from benign lymphoproliferative diseases.

“This award is a further validation of the clinical utility of RNAscope technology. We are very pleased that NCI has recognized the diagnostic potential of RNAscope technology and are grateful for its continued support”, commented by Dr Yuling Luo, President and CEO of ACD.

Detection of B-cell clonality by demonstrating the restricted expression of one of the two immunoglobulin light chains (kappa or lambda) provides valuable molecular information for the diagnosis of NHLs. Formalin-fixed paraffin-embedded (FFPE) tissue is often the only sample type available for diagnostic testing in many clinical settings, however there has been a long-standing technical challenge in detecting light chain mRNAs in these tissues.

“In Phase I, we developed a manual RNAscope-based assay for light chain mRNAs and demonstrated that it allowed determination of light chain restriction in virtually all types of NHL using FFPE with 99% concordance with the current gold standard assay flow cytometry using fresh tissue”, said Xiao-Jun Ma, Ph.D., ACD’s Chief Scientific Officer, and Principal Investigator.

“This is an important advance in our ability to accurately diagnose B-cell lymphomas because conventional IHC (immunohistochemistry) and CISH (chromogenic in situ hybridization) methods to establish clonality simply don’t work for the majority of NHLs for various reasons”, said James Cook, M.D/Ph.D., hematopathologist and co-investigator at Cleveland Clinic.

The Phase II grant will develop a fully automated assay and advanced image analysis algorithms for objective interpretation to facilitate clinical adoption.

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