In 2011, there were 34 partnerships between companion diagnostics makers and drug firms, up 36% from 2010. In the first quarter of 2012, 10 such partnerships were established. In July, QIAGEN’s companion diagnostic for Bristol-Myers Squibb and Eli Lilly’s colorectal cancer treatment Erbitux received FDA approval. Iressa, AstraZeneca’s drug for lung cancer introduced in 2002, has been more successful since QIAGEN developed its companion diagnostic in 2009. Roche now offers a companion test with 60% of its experimental drugs. Despite the rising popularity of companion tests, drug firms, which generally pay the cost of developing companion diagnostics, are wary of the willingness of drug buyers to pay more for these types of treatments. A 2011 Tufts Center for the Study of Drug Development study found uncertainty over the utility of such tests. As knowledge of diseases increase, the significance of a certain genetic mutation may decrease. Similar lab-developed tests from hospitals and universities also raise a competitive concern. Companion diagnostics makers are calling for stricter regulations for such tests. Some drug firms are also developing their own companion tests, but cannot always do so and would prefer to work with companion diagnostics makers.

Source: Financial Times