CellCarta and Waters Forge Partnership for Companion Diagnostics

The collaboration targets a more cohesive path for drug developers, spanning from initial assay innovation to global commercialization. Waters provides the technical infrastructure, including instrumentation, reagents, and analytical software, while CellCarta manages the deployment across its worldwide laboratory network. This integration is designed to support clinical trials through all phases, ensuring consistent analytical evidence for regulatory submissions.

A key focus of the partnership involves optimizing cross-border diagnostic programs, particularly between China and international markets. Leveraging CellCarta’s CAP-accredited facility in Jining, the companies intend to simplify the complex regulatory and logistical requirements for sponsors seeking to include China in multinational clinical trials. Todd Chermak, President of CellCarta, noted that the combined model is intended to reduce program complexity and allow for faster, data-driven decisions regarding scalability.

Technically, the venture emphasizes next-generation flow cytometry, utilizing high-sensitivity analysis to translate cellular insights into standardized clinical assays. Brent Gaylord, Vice President of Waters Biosciences, stated that the partnership facilitates the deployment of these high-value insights across diverse geographies, ensuring continuity as programs move from early-stage development to late-stage clinical implementation.