Abstract
In 1998 the monoclonal antibody trastuzumab obtained regulatory approval for the treatment of human epidermal growth factor receptor 2 (HER2)–positive metastatic breast cancer together with the immunohistochemical assay, the HercepTest. This assay identified patients who harbored tumors overexpressing HER2 and who were the ones likely to respond to trastuzumab. The HercepTest became the first companion diagnostic (CDx), and since then, an increasing number of targeted anticancer drugs have been developed together with a molecular diagnostic assay using the drug-diagnostic codevelopment model. Within the last few years the regulatory framework for this type of assay has been established, and according to the US Food and Drug Administration a CDx is defined as an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product. Today companion and complementary diagnostics are considered important elements in the realization of precision medicine.
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