CellCarta has entered into a strategic partnership with Waters Corporation to develop companion diagnostic (CDx) and next-generation flow cytometry solutions for pharmaceutical and biotechnology companies.
Under the framework, the two organisations will initially focus on flow cytometry-based programmes.
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The collaboration is designed to support drug sponsors through the entire diagnostic pathway, covering initial biomarker strategy, clinical trials, regulatory filings, and international commercialisation.
Waters Corporation will contribute technological resources to the initiative, supplying instruments, reagents, standardised panels, assay development services, and software analysis, as well as handling in vitro diagnostic (IVD) and custom reagent commercialisation where required.
CellCarta will deploy these assays across its international laboratory network, managing Phase I to Phase III trial testing, analytical and clinical evidence generation, regulatory compliance, logistical assistance, and commercial laboratory operations.
The collaboration builds on operational alignment between CellCarta’s College of American Pathologists (CAP)-accredited facility in Jining, China, and BD flow cytometry platforms.
This setup provides infrastructure for international sponsors intending to incorporate China into multinational biomarker and CDx programmes, while also assisting China-based biopharmaceutical firms seeking to expand diagnostic and therapeutic strategies internationally.
CellCarta president Todd Chermak said: “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, commercialisation.
“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 programme continuity and make earlier, more informed decisions about how to scale their programmes.
“We are already engaging pharmaceutical and biotechnology companies on near-term opportunities where this combined model can make a meaningful difference.”
CellCarta operates contract research organisation (CRO) facilities holding CAP accreditations and Clinical Laboratory Improvement Amendments (CLIA) certifications across Australia, Belgium, Canada, China, and the US.
Its services span genomics, histopathology, immunology, proteomics, sample management, and logistics across drug discovery and clinical development phases.
