June 4, 2024
A companion diagnostic (CDx) is an in vitro diagnostic providing essential information for the safe and effective use of a corresponding therapeutic product. By identifying patients most likely to benefit from or who are at risk of adverse events from a therapy, CDx can help guide decisions for targeted treatment strategies—which is why many regulatory bodies now recommend incorporating CDx within cell and gene therapy (CGT) programs. However, for many developers, questions remain about when CDx are truly needed, how to choose the right CDx partner and the kind of testing required for CDx assays. To gain clarity on CDx strategy and best practices, we spoke with Devin Craven, associate director of regulatory affairs for Labcorp, and Laura Huning, a scientist for Labcorp’s diagnostic development services.