CellCarta strikes landmark deal with Sonic Healthcare to scale companion diagnostics to market
CellCarta, the Montreal-based contract research organisation (CRO), has announced a strategic partnership with Sonic Healthcare USA, Inc. (SHUAS) that positions the company to bridge the critical gap between companion diagnostic (CDx) regulatory approval and broad commercial deployment across the United States.
The agreement establishes Sonic as the first committed commercial laboratory partner within CellCarta’s emerging Lab Network – a framework designed to support biopharma sponsors pursuing a centralised, single-site Premarket Approval (PMA) CDx strategy whilst retaining a credible route to scale.
A model built around the single-site approval pathway
At the heart of the partnership is CellCarta’s single-site PMA CDx bridging model. Under this framework, CellCarta develops the companion diagnostic, assembles the analytical and clinical evidence package, and navigates both US FDA and European In Vitro Diagnostic Regulation (IVDR) regulatory pathways before performing centralised CDx testing. Laboratory network partners such as Sonic then assume responsibility for provider-facing commercialisation – managing order flow, customer relationships, and market access execution across target geographies via a send-out model to CellCarta laboratories.
The model is intended to serve oncology, autoimmune disease, and other precision medicine indications where the demands of regulatory rigour, assay integrity, and commercial execution are particularly acute.
Addressing a structural challenge in precision medicine
Single-site CDx strategies have historically been viewed with scepticism by sponsors concerned about limiting patient reach at the point of commercialisation. CellCarta’s approach attempts to resolve this tension by preserving assay continuity at a centralised site whilst enabling geographic access through established laboratory networks.
“Biopharma companies increasingly want a faster, more controlled path to companion diagnostic approval, but they also need a credible route to commercialisation once that approval is secured,” said Dusty Tenney, Chief Executive Officer of CellCarta. “With Sonic as our first committed commercial laboratory partner, we are creating a bridge from single-site PMA and centralised IVD approval strategies to broader physician and patient access.”
Ehab A. El-Gabry, MD, Chief Medical Officer and Head of Companion Diagnostics at CellCarta, noted that the model also preserves long-term scalability through downstream bridging to large diagnostic manufacturers. “We preserve long-term scalability by bridging to large diagnostic manufacturers – combining the strengths of centralised and decentralised CDx models,” he said.
Sonic’s network as the commercial interface
Sonic Healthcare USA operates a nationwide clinical and anatomic pathology network guided by medical leadership. Its involvement is intended to ensure validated testing reaches clinicians and patients efficiently within routine clinical practice.
“By combining CellCarta’s expertise in companion diagnostic development with Sonic’s clinical laboratory network and Sonic Research Network’s capabilities, we can help ensure that validated testing is available to physicians and patients when and where it is needed in clinical practice,” commented Mohamed Salama, MD, Chief Medical Officer of Sonic Healthcare USA.
Expansion plans under way
CellCarta has indicated it is in active discussions with additional laboratory partners, with the intention of building a broader global network over time. The company expects its Lab Network infrastructure to grow in parallel with increasing market interest in centralised CDx development models, with an in vitro diagnostic (IVD) kitted solution providing the mechanism for future geographic expansion.
For more information, visit: https://cellcarta.com/cdx-services
