In order to meet increasing demands for safety and cost effectiveness, more drugs are being developed with diagnostic tests to target specific patient populations. This summer, the FDA issued guidelines for drug and diagnostic combinations, and the FDA approved two such products: Xalkori for lung cancer and Zelboraf for treating melanoma. The Personalized Medicine Coalition estimates that there are 70 companion diagnostics for drugs available, but many were developed after the drugs’ release or are not required. Developing a drug and diagnostic test is complicated by the need to determine how to test the effects of the drug and to synchronize both research and FDA approval. Also, drug firms expect high profit margins, while diagnostic companies usually operate with low profit margins and development costs. Drug firms often pay to develop the accompanying diagnostic to offset the risk taken by diagnostic companies that the drug will not reach the market. In order to deter competition from labs and other diagnostic makers that can offer competing tests, companion-diagnostic companies want the FDA to cite their tests by name on the drug label. However, the FDA has resisted such efforts so far.

Source: New York Times