MANSFIELD, Mass., Sept. 26, 2012 /PRNewswire/ -- PrimeraDx, Inc., a molecular diagnostics company, announced today that they were awarded a grant by the National Cancer Institute-sponsored Innovative Molecular Analysis Technologies (IMAT) Program to develop an assay to rapidly detect diffuse large B-Cell lymphoma (DLBCL) subgroups. This single-tube gene expression profiling assay will be used for classifying DLBCL subgroups, thereby facilitating rapid diagnosis, choosing treatment options, and predicting the likelihood of response to therapy and survival. The assay will be developed on PrimeraDx's ICEPlex system, a highly multiplexed, automated real-time PCR platform, utilizing formalin-fixed, paraffin-embedded (FFPE) specimens.
"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. This award from the NCI is an important recognition of the ICEPlex system's capabilities in oncology diagnostics," said President and CEO, Matt McManus, MD, PhD. "Developing this assay will significantly advance the ability to translate tumor biology into actionable clinical diagnoses."
DLBCL accounts for around 30% of all non-Hodgkin lymphomas and thus is the most common subtype of this cancer in the United States. Standard gene expression profiling (GEP) with snap frozen tissues has been used to classify the cell-of-origin of DLBCL subtypes and provide prognostic value. Germinal Center B cell and Activated B cell are the two major subtypes of DLBCL, generally associated with a favorable prognosis and poorer prognosis, respectively. Both types have distinctive genetic variations, including over-expression of different pathways that may serve as therapeutic targets. Because GEP currently requires frozen tissue, it has not been a practical testing methodology in many cases of lymphoma. However, precise GEP classification of cell-of-origin using FFPE tissues is now critical for analysis of clinical trial results and planning new trials with targeted agents, necessitating a novel approach such as that offered by PrimeraDx.
"Single-reaction gene expression profiling is only one of the many capabilities the ICEPlex system offers," added CSO Lilly Kong. "We are excited that our technology can revolutionize cancer diagnostics by simplifying complicated, multi-tube, multi-platform tests into a single-tube format. Additional examples of our unique capabilities in oncology diagnostics include a number of highly multiplexed mutation panels, like KRAS and EGFR, as well as copy number variation with expression, like our cMet/EGFR assay."
PrimeraDx is a molecular diagnostics company that has developed and is commercializing a novel, game-changing clinical platform which combines PCR with capillary electrophoresis. The result of combining these two well-known technologies into a bench-top instrument is the ability to deliver highly multiplexed and quantitative answers to the clinic. The company is pursuing a two-pronged strategy to sell the system in an Open Platform Mode to clinical labs and to independently develop high-value molecular diagnostic products. Users can easily design very complex multi-modal assays that test for disparate target types, like SNPs, expression biomarkers, microRNAs and fusion genes. PrimeraDx's technology represents the next generation of quantitative, multiplex PCR. The Company is backed by a strong group of experienced venture-capital investors, including Abingworth, InterWest Partners, CHL Medical Partners, and Malaysian Technology Development Corporation. The Company's website is: www.primeradx.com or www.multiplexpcr.com.
CONTACT: Ted Myles, CFO, (508) 618-2300
SOURCE PrimeraDx, Inc.