FISH-based test is intended to identify deletions in TP53 gene.
Abbott will collaborate with Merck & Co. to evaluate the use of a FISH-based companion diagnostic test to aid in the development of a Merck investigational cancer therapy. Under terms of the agreement, Abbott will develop a test based on its FISH technology that can identify deletions of the TP53 gene in cancer patients.
FISH-based companion diagnostic tests are designed to identify specific DNA sequences. It can identify whether too many or too few copies of a particular gene are present in the body’s cells or whether certain genes have rearrangements that play an active role in disease progression.
“As one of the early pioneers in companion diagnostics, we believe that linking genetic testing with drug development at the earliest stages can increase the effectiveness and predictability of medicines and help physicians make more informed treatment decisions,” remarks Stafford O’Kelly, head of Abbott’s molecular diagnostics business.
Abbott’s portfolio of companion diagnostic tests includes the PathVysion® Her2 DNA Probe Kit for use in selecting breast cancer patients who could receive Herceptin®. Abbott’s Vysis ALK Break Apart FISH Probe kit is approved for use in identifying non-small-cell-lung cancer (NSCLC) patients for Xalkori.
Abbott says that it has personalized medicine collaborations in place with a number of pharmaceutical companies including Pfizer and GlaxoSmithKline. The company inked its deal with Pfizer in August 2009 to develop a companion test for NSCLC candidate PF-02341066.
In November 2011, Abbott expanded its arrangement with GSK to include the development of a companion diagnostic in support of GSK’s cancer immunotherapy research program. Abbott will develop a PCR test to screen NSCLC tumors for the expression of the PRAME antigen. Prior arrangements with GSK, announced in July 2009 and March 2010, focused on PCR tests to screen NSCLC and melanoma tumors for expression of the MAGE-A3 antigen.