By Ben Butkus
This story has been updated from a version posted Oct. 25 to include comments from a GlaxoSmithKline spokesperson.
Life Technologies said yesterday that it has inked an agreement with GlaxoSmithKline Biologicals to develop a qPCR-based molecular diagnostic assay to help select patients who may benefit from a GSK candidate cancer immunotherapy.
The agreement is Life Tech's first development deal with a pharmaceutical company in the area of companion diagnostics, a market that the company has been hinting about entering for several months.
For GSK, the partnership complements an ongoing collaboration it has with Abbott to develop a similar molecular test for the same therapeutic candidate.
Under the terms of their agreement, Life Tech and GSK will develop and commercialize a qPCR-based test to detect MAGE-A3-positive patients that are most likely to benefit from GSK's investigative MAGE-A3 Antigen-Specific Cancer Immunotherapeutic, or ASCI.
MAGE-A3 is a tumor-specific antigen that is expressed in non-small cell lung cancer, skin cancer, and a variety of other cancers, but not in normal cells. GSK's candidate immunotherapy is currently in two clinical trials: MAGRIT, a phase III study evaluating its efficacy and safety as an adjuvant treatment in resected non-small cell lung cancer; and DERMA, a phase III study evaluating the efficacy and safety of the immunotherapy as an adjuvant treatment in patients with stage 3B or 3C melanoma that has spread to the lymph node.
The Life Tech-GSK-developed test will be a multi-gene expression in vitro diagnostic assay using Life Tech's Taqman low-density arrays, microfluidic cards that enable users to run as many as 384 simultaneous Taqman-based qPCR assays. The cards can be run on Life Tech's ViiA 7, 7900HT Fast, or new QuantStudio 12K Flex real-time PCR instruments; however, a GSK spokesperson told PCR Insider in an e-mail that the new assays would be developed to run on the ViiA 7.
Neither the Taqman Array Cards nor ViiA7 are approved for animal or human therapeutic or diagnostic use. As such, the companies said that the companion diagnostic assays developed using the technology would be submitted for premarket approval by the US Food and Drug Administration.
Financial terms of the agreement were not disclosed.
GSK already has a companion diagnostic-development deal in place with Abbott for the same MAGE-A3 biomarker and the same candidate therapy and cancer indications. Under the original agreement, announced in 2009, Abbott and GSK were to develop a companion diagnostic test on Abbott's m2000 automated molecular testing system that would help select MAGE-A3-positive lung cancer patients for the ASCI.
Then, in March 2010, Abbott announced that the companies had expanded the original agreement to develop similar assays to determine whether patients whose melanoma had spread to the lymph node would benefit from the same ASCI (PCR Insider, 3/4/2010).
The GSK spokesperson said that the company is partnering with Life Tech "in addition" to the work that it is carrying out with Abbott, which is progressing as originally planned.
More specifically, the spokesperson said that GSK's deal with Life Tech "is for a diagnostic which would be used for [a] gene signature as a second stage of the patient gene profiling," and that this gene signature, if successful, "will enable a better prediction of responders of the MAGE-A3-positive patient population [and] potentially increase the number of responders and therefore the efficacy of [MAGE-A3 ASCI]."
Abbott received 510(k) approval from the FDA in June 2010 for the m2000 system along with its combined molecular diagnostic test for chlamydia and gonorrhea (PCR Insider, 7/1/2010).
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