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Response Genetics to Provide GSK with PCR-Based BRAF Mutation Analysis

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This article was originally published on May 11.

Response Genetics said today that it has signed a non-exclusive licensing deal with GlaxoSmithKline in the area of BRAF mutational analysis.

Under the agreement, GSK gains certain rights to Response Genetics' PCR analysis technology and diagnostic expertise to assess BRAF mutations in human tumor samples, Response Genetics said.

In addition, GSK will make payments to Response Genetics upon achieving certain undisclosed milestones. Additional financial details were not disclosed.

The BRAF gene encodes B-Raf proto-oncogene serine/threonine-protein kinase, or B-RAF, a protein involved in cell signaling and cellular growth and differentiation. Specific mutations of BRAF have been correlated with the development of a variety of cancers.

Response Genetics and GSK have worked together previously. In 2008, the companies inked a deal to conduct gene-expression screening studies for a Phase III trial of GSK's investigational MAGE-A3 antigen-specific immunotherapeutic for non-small cell lung cancer.

As reported in 2008 in PCR Insider sister newsletter Pharmacogenomics Reporter, terms of that collaboration called for Response Genetics to perform assays in formalin-fixed, paraffin-embedded tissue samples. The company’s methodology involves micro-dissection of FFPE tumor samples, RNA extraction, and analysis using either Life Technologies' Applied Biosystems TaqMan PCR or genome-wide microarray analysis (PGx Reporter, 1/30/2008).

PGx Reporter had also reported that Response Genetics licensed from the University of Southern California technology for extracting mRNA from FFPE tumor specimens; and that it holds a non-exclusive license to use Roche's PCR, homogenous PCR, and RT-PCR technologies.

It is unclear which of the aforementioned technologies Response Genetics will be using in the new deal with GSK. A company representative was not immediately available for comment.

In a statement, Response Genetics President and CEO Kathleen Danenberg said that "as a provider of genetic testing services to GSK, we are pleased to continue to support GSK's clinical trial program."

Using Response Genetics' technology to identify specific genetic mutations, such as in BRAF, "we hope to enable the development of diagnosis tools for disease prognosis that may aid in treatment decisions," Danenberg added.

Response Genetics offers services to physicians based on its ResponseDx series of proprietary PCR-based tests used to analyze the expression of genes that correlate with response to commonly used chemotherapy agents, the company said.

Its ResponseDx colon, lung, and gastric genetic test panels are available in the US through direct sales and through NeoGenomic Laboratories. In Australia and certain Asian countries, ReponseDx tests are available through Genetic Technologies. All tests are performed at Response Genetics' CLIA-certified laboratory.

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