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Abbott, GSK To Develop Molecular Diagnostic Test For Skin Cancer

Abbott has entered into an agreement with GlaxoSmithKline (GSK) to develop a molecular diagnostic test intended for use as an aid in selecting patients who may benefit from a skin cancer treatment in development by GSK.

GSK’s MAGE-A3 ASCI (Antigen-Specific Cancer Immunotherapeutic) candidate is currently being evaluated as an adjuvant treatment in melanoma biopsy specimens in the Phase III clinical study Derma. To be eligible to receive GSK’s MAGE-A3 ASCI, patients must have MAGE-A3 expressing melanoma tumors.

Under terms of the agreement, Abbott, in conjunction with GSK, will develop and commercialize a PCR (polymerase chain reaction) test for use on the Abbott m2000 automated molecular instrument system. The test will be designed to detect MAGE-A3, a tumor-specific antigen that is expressed in skin cancer and a wide variety of other cancers, but not in normal cells. In July 2009, both companies announced a similar collaboration and Phase III investigation for the MAGE-A3 marker in non-small-cell lung cancer.

Currently, there are no nucleic acid-based tests approved by the FDA for use in identifying patients who may derive treatment benefits from targeted skin cancer therapies. Abbott, in collaboration with GSK, will seek regulatory approval for the test in several markets, including the US and Europe.

The highly specific mode of action of GSK’s ASCIs is linked to the development of diagnostic tools to aid in selecting patients eligible for the treatment, depending on the expression of the tumor antigens. MAGE-A3 is a tumor-specific antigen that is expressed in a large variety of cancers, including melanoma, non-small cell lung cancer, liver and bladder cancer, with no expression in normal cells. MAGE-A3 ASCI is an investigational compound and is not approved for use in any indication in any country at this time.

Stafford Kelly, head of molecular diagnostics business at Abbott, said: “This is an exciting continuation of our important collaboration with GSK, a leading company in cancer immunotherapy research. 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.”