By Charlotte Schubert
When Stephen Little co-founded a molecular diagnostics company in 2001, he gave numerous presentations to pharmaceutical companies touting the benefits of tests that can tell which patients are likely to respond to a particular therapy or experience side effects. But most drugmakers were focused on blockbusters, and, since these so-called ‘companion diagnostics’ divide patient populations into smaller groups, they threatened to contract, not expand, their markets. As such, Little recalls, “there was not a great deal of enthusiasm.”
Ten years later, the tide has changed for Little and the field of companion diagnostics. In 2009, Little’s company, Manchester, UK–based DxS, was bought by the Dutch technology company Qiagen, where Little now serves as vice president of personalized health care. Qiagen currently has partnerships with more than 15 pharmaceutical companies, including, most recently, an agreement announced last month with Eli Lilly to develop a PCR-based test to detect mutations in the gene encoding Janus kinase 2 and thereby identify individuals with blood cancer who are likely to respond to a drug in early-stage development at the Indiana-based company.
This deal follows less than a month after the US Food and Drug Administration (FDA) approved two cancer drugs—Zelboraf (vemurafenib) for BRAF-mutation–positive metastatic melanoma on 17 August, and, a week later, Xalkori (crizotinib) for people with non–small-cell lung cancer driven by an ALK (anaplastic lymphoma kinase) fusion gene—together with their companion diagnostic tests. Notably, these two drug-diagnostic combined approvals represent divergent development strategies on the part of big pharma. The test accompanying Roche’s Zelboraf was developed in house at the Swiss drug giant’s diagnostics arm, Roche Molecular Diagnostics in Pleasanton, California. In contrast, New York–based Pfizer’s Xalkori comes with a diagnostic developed with Abbott Molecular of Des Plaines, Illinois.
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