Advanced Cell Diagnostics, Inc., (ACD), a provider of 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 lympho-proliferative diseases.
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.
“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,” says James Cook, MD, PhD, 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. Learn more about RNAscope technology.Read more