CellCarta and Waters partner to advance companion diagnostics

CellCarta has announced a strategic partnership with Waters Corporation, creating a framework to jointly pursue companion diagnostic (CDx) and next-generation flow cytometry opportunities with pharmaceutical and biotechnology companies.

The collaboration will initially emphasize flow cytometry-based programs. For CDx opportunities, the partnership aims to provide sponsors with a coordinated path from biomarker strategy through clinical development, regulatory submission, and global commercialization.

The complementary expertise of CellCarta and Waters spans assay innovation, development, validation, and global implementation. Waters provides underlying technology capabilities, including instrumentation, reagents, standardized panels, assay development, software analysis, and, where appropriate, custom reagent and IVD commercialization.

CellCarta leverages its extensive biomarker, translational research, and clinical development expertise to integrate and deploy the assay across its global CDx Lab Network, supporting Phase I-III clinical trial testing, generation of analytical and clinical evidence, regulatory and logistics support, and commercial laboratory services. Together, the companies aim to deliver standardized and globally scalable solutions for precision medicine.

The existing platform alignment between CellCarta’s CAP-accredited laboratory’s capabilities in Jining, China and BD flow cytometry platforms create a practical foundation for global sponsors seeking to include China in future multinational CDx and biomarker programs, as well as China-based biopharmaceutical companies preparing to expand their therapies and diagnostic strategies globally.

“For our biopharmaceutical sponsors, the business value of this partnership is clear: a more connected path from biomarker strategy through global clinical development and, where appropriate, commercialization,” said Todd Chermak, President of CellCarta.

“By combining CellCarta’s end-to-end laboratory capabilities with Waters’ diagnostic and CDx development expertise, and flow cytometry platforms, we can help sponsors reduce complexity, preserve program continuity and make earlier, more informed decisions about how to scale their programs. We are already engaging pharmaceutical and biotechnology companies on near-term opportunities where this combined model can make a meaningful difference.”

“Next-generation flow cytometry is expanding what laboratories can see by combining highly sensitive rare-cell analysis with greater standardization across the entire workflow,” added Brent Gaylord, VP/GM Reagents, Waters Biosciences, Waters Corporation.

“By combining CellCarta’s contract research organization expertise with Waters’ clinical assay development expertise and integrated instruments, reagents, and informatics, this collaboration is designed to help biopharmaceutical sponsors translate high-value cellular insights into clinical assays that can be consistently deployed across programs and geographies.”

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