Abbott and GlaxoSmithKline (GSK) have entered into a collaboration 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 antigen-specific cancer immunotherapeutic (ASCI) candidate is 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 tumours.
Under terms of the agreement, Abbott, alongside GSK, will develop and commercialise a polymerase chain reaction test for use on the Abbott m2000 automated molecular instrument system.
The test will be designed to detect MAGE-A3, a tumour-specific antigen that is expressed in skin cancer and a wide variety of other cancers, but not in normal cells.
There are no nucleic acid-based tests approved by the US Food and Drug Administration 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.