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Abbott, GSK Pen Melanoma MDx Collaboration

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Abbott said today that it will collaborate with GlaxoSmithKline to develop an automated molecular diagnostic test to determine which patients might benefit from a skin cancer drug candidate being developed by the British drug maker.

Abbott will develop and market a PCR-based test for use on its m2000 automated molecular system that will identify patients that have MAGE-A3, a tumor-specific antigen that is expressed in skin cancer and other cancers but is not expressed in normal cells.

There are currently no nucleic acid-based tests approved by the US Food and Drug Administration for identifying patients who may benefit from targeted skin cancer therapies, the company said.

Abbott said that it will collaborate with GSK to obtain regulatory approval for the test in several markets, including the US and Europe.

The MAGE-A3 antigen specific cancer immunotherapeutic (ASCI) drug candidate is in Phase III clinical studies as an adjuvant treatment in melanoma biopsy specimens.

"The agreement is indicative of our commitment to personalized medicine and our focus on developing innovative companion diagnostic tests that can be used to identify patients most likely to benefit from specific cancer therapies, Stafford O'Kelly, head of Abbott's molecular diagnostics business, said in a statement.

The two companies inked a similar diagnostic development agreement in July 2009 for an automated PCR-based test to use the MAGE-A3 marker to screen for non-small-cell lung cancer tumors.

According to the American Cancer Society, there are an estimated 69,000 cases of melanoma each year.

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