Qiagen filed its application for FDA approval of a test for epidermal growth factor receptor in lung tumors simultaneously with Boehringer Ingelheim's request for approval of a drug that targets the gene mutation. Diagnostic tests help clinicians determine whether drugs that target specific gene mutations will work in individual patients, but insurers hesitate to reimburse diagnostics in the absence of proof that they improve drug efficacy. When tests are developed and approved in tandem with drugs, reimbursement is more likely, says Qiagen’s Stephen Little.
Companion diagnostics change cancer drug development
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