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Companion Diagnostic to Help Development of Cancer Therapy

By Labmedica International staff writers
Posted on 14 Mar 2012
A companion diagnostic test is to be created to aid in the development of an investigational cancer therapy.

Abbott (Abbott Park, Il, USA) will collaborate with Merck (Whitehouse Station, NJ, USA) to evaluate the use of a fluorescence in situ hybridization (FISH)-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 determine which patients are likely to benefit from a particular therapy. FISH technology 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 its fastest growing applications.

Abbott will develop a test based on its 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.

Abbott Molecular is a leader in molecular diagnostics. The company analyses DNA and RNA at the molecular level. "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.

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Image: Positive case of lung tissue stained for ALK with VENTANA ALK (D5F3) CDx Assay, a companion diagnostic immunohistochemical test in the final stages of the FDA premarket approval process (Photo courtesy of Ventana Medical Systems and PRNewsFoto).

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