A recent string of announcements of partnerships aimed at expanding companion diagnostic (CDx) codevelopment reflects the commitment of pharmaceutical companies to develop targeted therapeutics, particularly for their cancer product pipelines. Yet for these tests to be commercially successful, experts say test developers must incorporate a steadfast focus on the tests’ clinical utility during all stages of development. The 1998 Herceptin/HercepTest approval for metastatic breast cancer marked the beginning of the era of CDx codevelopment. While there has been tremendous hope that such targeted therapeutics will increase the efficacy of cancer treatment and improve survival outcomes, there remains a limited number of approved CDx on the commercial market. “People said [HercepTest] was heralding in a new age—the way of the future. But another decade passed and right now we have relatively few CDx, leaving a lot of people asking what happened,” Kenneth Emancipator, M.D., a board member of the American Society for Clinical Pathology, explains to DTET. “But when you look at pharmaceutical companies’ current pipelines, I predict an explosion of CDx within five years.” Experts say demonstration of a test’s clinical utility is key to overcoming several large hurdles, namely reimbursement and regulatory approval, on the path to clinical adoption […]