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Abbott, GSK Add New Biomarker to Cancer Immunotherapy Companion Dx Agreement

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Abbott said this week that it has expanded an existing immunotherapy companion diagnostic development agreement with GlaxoSmithKline to include a new target antigen.

Specifically, under the expanded agreement Abbott will develop a PCR-based test for use on its m2000 automated molecular diagnostics platform to screen non-small cell lung cancer and melanoma tumors for the expression of the PRAME antigen as part of GSK's investigational cancer immunotherapy research program.

PRAME is a preferentially expressed melanoma antigen that is expressed in 69 percent of non-small cell lung cancer cases, as well as in a variety of other cancer types, including breast, ovarian, and bladder cancer, with limited expression in normal cells.

The original collaboration between Abbott and GSK, announced in July 2009, focused on the development of a PCR-based companion diagnostic on the m2000 to help select lung cancer patients expressing the MAGE-A3 antigen for treatment with GSK's investigational MAGE-A3 antigen-specific cancer immunotherapeutic, or ASCI.

Abbott and GSK expanded and extended that agreement in March 2010 to help select MAGE-A3-positive melanoma patients for treatment with the investigational therapy (PCR Insider, 3/4/2010).

"This expanded collaboration, along with Abbott's other recently announced partnerships in oncology, demonstrates the continued commitment Abbott is making to assess biomarkers linked to immunotherapies in various cancers," Stafford O'Kelly, head of Abbott's molecular diagnostics business, said in a statement this week.

The Abbott m2000 is an automated system for DNA and RNA testing that comprises the m2000sp module for automated sample extraction preparation and the m2000rt instrument for real-time PCR detection and analysis. The platform received 510(k) approval from the FDA in June 2010 along with a combined molecular diagnostic test for chlamydia and gonorrhea.

In October, GSK and Life Technologies announced that they had forged an agreement to develop a qPCR-based molecular diagnostic assay using Life Tech's Taqman low-density arrays to help detect MAGE-A3-positive patients most likely to benefit from GSK's MAGE-A3 ASCI (PCR Insider, 10/27/11).

Even though GSK's agreement with Life Tech was for the same MAGE-A3 target covered by its original agreement with Abbott, a GSK spokesperson noted in October that the two development programs were for different stages of patient profiling, and that the Abbott agreement was progressing as originally planned.

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