Abbott and Merck collaborate to develop companion diagnostic test

Abbott announced today that it will collaborate with Merck to evaluate the use of a FISH (fluorescence in situ hybridization)-based companion diagnostic test to aid in the development of a Merck investigational cancer therapy. FISH-based companion diagnostic tests are designed to identify specific DNA sequences to help guide physicians in determining which patients are more or less likely to benefit from a particular therapy.

Under terms of the agreement, Abbott will develop a test based on its proprietary FISH technology, intended to identify deletions of the TP53 gene in cancer patients. The Abbott FISH assay will be evaluated in clinical trials to help identify patients more likely to respond favorably to Merck’s investigational cancer therapy.

“Our goal through this collaboration, and others like it, is to ensure that the right medicine gets to the right patient,” said Stafford O’Kelly, head of Abbott’s molecular diagnostics business. “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.”

Abbott’s portfolio of companion diagnostic tests includes the PathVysion® HER-2 DNA Probe Kit, which represents one of the first examples of innovations in the field of personalized medicine. The test is approved for use in selecting breast cancer patients for whom Herceptin® (trastuzumab) therapy is being considered. In addition, Abbott’s Vysis ALK Break Apart FISH Probe kit was approved in 2011 for use in identifying non-small cell lung cancer patients for XALKORI® (crizotinib) treatment. Abbott has personalized medicine collaborations in place with a number of pharmaceutical companies, including Pfizer and GlaxoSmithKline.

About FISH

FISH technology has a variety of uses. 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. Cancer diagnostics is one of the fastest growing applications.