Advanced Cell Diagnostics (ACD) has received a two-year $1.4 million grant from the National Cancer Institute (NCI) to develop and validate a diagnostic test for differentiating various B-cell non-Hodgkin lymphomas from benign lymphoproliferative diseases.
The grant was awarded under NCI's Small Business Innovation Research Phase II program, according to the company. ACD and its academic partner, the Cleveland Clinic, will use the funds to develop a fully automated assay and advanced image analysis algorithms for objective interpretation. The work will facilitate clinical adoption of the test, ACD said.
The test will be based on ACD's RNAscope technology for detecting RNA with high specificity. The technology can detect down to the single-molecule level and can be used on formalin-fixed, paraffin-embedded tissue. RNAscope has been available on a research-use only basis, but ACD plans to launch an RNAscope-based test for human papillomavirus and head and neck cancer in the clinical diagnostics market later this year in Europe.
In phase I work, ACD developed a manual RNAscope assay for light chain mRNAs, which demonstrated that it allowed determination of light chain restriction in nearly all types of non-Hodgkin lymphomas using FFPE with 99% concordance with the current gold standard assay of flow cytometry using fresh tissue, said ACD investigator Xiao-Jun Ma.
