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ACD Nabs $1.4M SBIR Grant to Develop, Validate Technology for B-cell non-Hodgkin Lymphomas

NEW YORK (GenomeWeb) – Advanced Cell Diagnostics today announced it has been awarded a two-year $1.4 million grant from the National Cancer Institute 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. ACD and its partner the Cleveland Clinic will use it to develop a fully automated assay and advanced image analysis algorithms for objective interpretation. The work is anticipated to 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 Hayward, Calif.-based 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 "and demonstrated that it allowed determination of light chain restriction in virtually all types of [non-Hodgkin lymphomas] using FFPE with 99 percent concordance with the current gold standard assay [of] flow cytometry using fresh tissue," ACD CSO Xiao-Jun Ma, who also is the principal investigator on the grant, said in a statement.