CellCarta and Sonic Healthcare establish strategic partnership to commercialize companion diagnostics through lab network
Sonic becomes the first committed commercial laboratory partner in CellCarta’s single-site PMA CDx bridging strategy, supporting oncology, autoimmune and other precision medicine programs
5 Jun 2026Industry news
CellCarta has entered into a strategic partnership with Sonic Healthcare USA, Inc. ('SHUAS' or 'Sonic') to commercialize companion diagnostics (CDx) developed through CellCarta’s single-site PMA CDx bridging model.
Under this agreement, Sonic becomes the first committed commercial laboratory partner in the CellCarta Lab Network, supporting the deployment of oncology, autoimmune and other precision medicine companion diagnostics across key geographies.
Overview of the strategic partnership
The strategic partnership between CellCarta and Sonic Healthcare USA is designed to help biopharma companies move efficiently from companion diagnostic development and regulatory approval to commercial deployment through a scalable, provider-facing laboratory network.
Within this model:
- CellCarta develops the companion diagnostic assay, generates the analytical and clinical evidence package, supports U.S. FDA and European IVDR regulatory pathways, and performs CDx testing at its laboratories.
- Network partners such as Sonic serve as the direct interface with healthcare providers and patients, enabling test ordering, customer relationships and market access execution in target regions.
Sonic will act as the first committed laboratory partner in the CellCarta Lab Network, supporting commercialization of companion diagnostics in oncology, autoimmune disease and other precision medicine indications where rapid assay deployment, regulatory rigor and commercial execution must be closely aligned.
Single-site PMA CDx bridging model and commercialization
CellCarta’s Lab Network strategy is built around a single-site, centralized CDx development and approval pathway that can be practically bridged to commercial scale through an in vitro diagnostic (IVD) kitted solution.
Under this approach, biopharma sponsors can:
- Pursue a centralized, high-quality, single-site approval and testing strategy for their companion diagnostics.
- Maintain assay continuity and quality while preparing for broader commercialization.
- Leverage an IVD kitted solution to support long-term scalability and geographic expansion.
By combining CellCarta’s assay development, regulatory and testing capabilities with Sonic’s extensive provider-facing clinical laboratory network, the partnership aims to accelerate access to approved companion diagnostics without disrupting established testing workflows.
Sonic Healthcare USA’s role in expanding access
Sonic Healthcare USA’s participation in the CellCarta Lab Network reflects its focus on expanding access to high-quality diagnostic testing that informs clinical decision-making.
Through this partnership, Sonic will:
- Act as a key commercial interface for providers and patients.
- Support order flow and customer engagement for CellCarta-developed companion diagnostics.
- Help implement market access strategies across target geographies for oncology, autoimmune and other precision medicine programs.
Future expansion of the CellCarta Lab Network
CellCarta expects its Lab Network strategy to expand over time, creating a broader commercialization infrastructure for sponsors that select a centralized CDx development and approval model.
Key elements of this expansion include:
- Building a wider network of laboratory partners to support geographic growth.
- Preserving optionality for future regional expansion and downstream bridging strategies through an IVD kitted solution.
- Providing biopharma sponsors with a flexible framework that supports both current centralized testing and future decentralized deployment through large diagnostic manufacturers.
CellCarta is in active discussions with additional laboratory partners, reflecting increasing market interest in the model and the company’s intent to build a broader global network to support precision medicine companion diagnostics.
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Frequently asked questions
How does the CellCarta and Sonic Healthcare USA strategic partnership support commercialization of companion diagnostics in oncology, autoimmune disease, and precision medicine?
The strategic partnership between CellCarta and Sonic Healthcare USA is designed to help biopharmaceutical companies move efficiently from companion diagnostic (CDx) development and regulatory approval to commercial deployment.
CellCarta develops the companion diagnostic assays, generates analytical and clinical evidence, supports U.S. FDA and European IVDR regulatory pathways, and performs CDx testing at its laboratories.
Sonic Healthcare USA acts as the first committed commercial laboratory partner in the CellCarta Lab Network, serving as the direct interface with healthcare providers and patients. Through Sonic’s provider-facing clinical laboratory network, the partnership supports test ordering, customer relationships, and market access execution for oncology, autoimmune, and other precision medicine companion diagnostics across key geographies.
What is CellCarta’s single-site PMA CDx bridging model, and how does it enable scalable companion diagnostic commercialization for biopharma sponsors?
CellCarta’s Lab Network strategy is built around a single-site, centralized CDx development and approval pathway that can be bridged to commercial scale through an in vitro diagnostic (IVD) kitted solution.
Under this single-site PMA CDx bridging model, biopharma sponsors can pursue a centralized, high-quality approval and testing strategy for their companion diagnostics while maintaining assay continuity and quality. At the same time, they can prepare for broader commercialization by leveraging an IVD kitted solution to support long-term scalability and geographic expansion.
This model creates a bridge from single-site PMA and centralized IVD approval strategies to broader physician and patient access, combining the strengths of centralized and decentralized CDx models without disrupting established testing workflows.
What role will Sonic Healthcare USA play in the expansion of the CellCarta Lab Network and global access to precision medicine companion diagnostics?
Sonic Healthcare USA will act as a key commercial interface within the CellCarta Lab Network, focusing on expanding access to high-quality diagnostic testing that informs clinical decision-making. Through this partnership, Sonic will support order flow and customer engagement for CellCarta-developed companion diagnostics and help implement market access strategies across target geographies for oncology, autoimmune, and other precision medicine programs.
As CellCarta actively engages additional laboratory partners to build a broader global network, Sonic’s participation demonstrates how established provider-facing laboratory networks can enable validated testing to be available to physicians and patients when and where it is needed, while preserving optionality for future regional expansion and downstream bridging strategies through an IVD kitted solution.