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NCI Funds PrimeraDx for Lymphoma Assay

NEW YORK (GenomeWeb News) – PrimeraDx has landed a grant from the National Cancer Institute to develop a gene expression profiling assay that can rapidly detect diffuse large B-Cell lymphoma (DLBCL) subgroups, making it easier to diagnose the disease, select treatment options, and predict the likelihood of patient response to therapy and survival.

The company will use the $335,186 grant, funded under the Innovative Molecular Analysis Technologies Program, to develop the assay on its ICEPlex PCR-based platform, which uses formalin-fixed, paraffin-embedded specimens.

According to Mansfield, Mass.-based PrimeraDx, DLBCL accounts for around 30 percent of all non-Hodgkin lymphomas and is the most common sub-type of this cancer in the US.

"In the clinic today there is an unmet need for quantitative, multiplexed, sensitive, and robust assays that can use FFPE as a source of tissue for genetic analysis," PrimeraDx President and CEO Matt McManus said in a statement. "Developing this assay will significantly advance the ability to translate tumor biology into actionable clinical diagnoses."

Archives of FFPE tumors are a valuable resource for translational cancer genomics studies, but using FFPE tissue is challenging because it often contains RNA that is fragmented during fixation and storage, making it less suitable for microarray analysis, according to PrimeraDx's project proposal filed with NCI.

The company expects that its assay will be able to detect, quantify, and classify the two main subtypes of DLBCL and will facilitate a timely diagnosis of the tumor type.

PrimeraDx said in the proposal that it plans to adapt its STAR technology and its ICEPlex instrument to create the assay, and to validate and verify the test's analytical performance by conducting a concordance study against a reference microarray.