Sonic becomes the first committed commercial laboratory partner in CellCarta’s single-site PMA CDx bridging strategy, supporting oncology, autoimmune and other precision medicine programmes.
CellCarta, a leading global CRO laboratory to the biopharmaceutical industry, today announced a Strategic Partnership with Sonic Healthcare USA, Inc. (“SHUAS” or “Sonic”) to launch the first commercial laboratory relationship in CellCarta’s Lab Network strategy, designed to support the commercialisation of companion diagnostics developed through CellCarta’s single-site PMA CDx bridging model.
The Strategic Partnership marks an important step in CellCarta’s strategy to help biopharma companies move from companion diagnostics development and regulatory approval to commercial deployment through a scalable provider-facing laboratory network. Under this model, CellCarta develops the CDx, generates the analytical and clinical evidence package, supports U.S. FDA and European IVDR regulatory pathways, and performs the CDx testing. Network partners such as Sonic support commercialisation by serving as the direct interface with providers and patients, helping enable order flow, customer relationships, and market access execution across target geographies.
Sonic will serve as the first committed laboratory partner in the CellCarta Lab Network. The partnership is intended to support companion diagnostic commercialisation in oncology, autoimmune disease and other precision medicine settings where rapid assay deployment, regulatory rigour and commercial execution must work together.
CellCarta’s model is designed to address a growing need in precision medicine: enabling sponsors to pursue a centralised, high-quality, single-site approval and testing strategy while also establishing a practical bridge to commercial scale through an IVD kitted solution. By combining CellCarta’s assay development, regulatory and testing capabilities with Sonic’s provider-facing laboratory network, the two companies aim to help biopharma sponsors accelerate access to approved companion diagnostics without disrupting assay continuity or compromising quality.
“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. “Our Lab Network strategy is built to solve that challenge. 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.”
“Too often, single-site CDx strategies are perceived as limiting patient reach,” said Ehab A. El-Gabry, MD, Chief Medical Officer and Head of Companion Diagnostics at CellCarta. “This model is different. We support sponsors end-to-end—from assay development through regulatory submission and enable commercialisation through laboratory partners with established provider networks, allowing seamless test ordering via a send-out model to CellCarta labs. Importantly, we preserve long-term scalability by bridging to large diagnostic manufacturers, combining the strengths of centralised and decentralised CDx models.”
“This collaboration reflects Sonic Healthcare USA’s continued focus on expanding access to high-quality diagnostic testing that informs clinical decision-making,” said Mohamed Salama, MD, Chief Medical Officer, Sonic Healthcare USA, Inc. “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.”
CellCarta expects its Lab Network strategy to expand over time, creating a broader commercialisation infrastructure for sponsors that choose a centralised CDx development and approval model today while preserving optionality for future geographic expansion and downstream bridging strategies through an IVD kitted solution.
The company is also in active discussions with additional laboratory partners, reflecting growing market interest in the model and CellCarta’s intent to build a broader global network over time.
To learn more about CellCarta’s companion diagnostic capabilities, visit https://cellcarta.com/cdx-services/.
