While the potential benefits of utilizing genomic data to stratify patients most likely to respond to a specific treatment have been highly touted, the actual process of developing companion diagnostics (CDx) is fraught with a high degree of financial risk for diagnostic manufacturers. While some of these economic perils come from the “mismatch” between the pharmaceutical and the diagnostics industries, laboratories producing generic versions of the CDx as laboratory-developed tests (LDTs) also pose a significant economic threat to in vitro diagnostics (IVD) developers. Despite some recent approvals by the U.S. Food and Drug Administration (FDA), only 18 CDx have been approved to date. Participants in the workshop Refining Processes for the Co-Development of Genome-Based Therapeutics and Companion Diagnostic Tests, hosted by the Institute of Medicine last year, shared concerns about the process of codevelopment of CDx, particularly the commercial aspects of such arrangements. The workshop summary, published in mid-February, highlights the challenges associated with CDx codevelopment as well as some possible solutions to accelerate progress in development of CDx. “Drug development and test development are inherently difficult to coordinate,” said Felix Frueh, Ph.D., then an entrepreneur-in-residence at investment firm Third Rock Ventures. “For the most part the timelines of the […]