CellCarta has added Tempus AI to its CDx Commercialization Lab Network, expanding the laboratory infrastructure available to biopharma companies seeking to bring companion diagnostics (CDx) into US oncology practice.
Tempus will become the second commercial laboratory partner in CellCarta’s network, joining Sonic Healthcare USA and strengthening the model’s focus on oncology diagnostics.
The partnership is designed to address a key challenge in companion diagnostic development: regulatory approval does not necessarily provide the commercial infrastructure needed for healthcare providers to order a test, or for patients to access it.
Under the collaboration, CellCarta will develop and validate companion diagnostics, generate analytical and clinical evidence, support regulatory submissions and conduct centralised immunohistochemistry (IHC) and tissue-based testing.
Following approval, Tempus will then support provider test ordering through its Tempus Hub platform.
Samples will then be routed to CellCarta for testing and results transmitted back to ordering healthcare providers.
The arrangement forms part of CellCarta’s CDx Accelerator Model, which is a modular framework covering four stages: Build, Validate, Launch and Transfer.
Biopharma sponsors can engage CellCarta at different points in the companion diagnostic development process, with commercial laboratory partners activated following regulatory approval.
CellCarta said in its statement that adding Tempus will strengthen the oncology capabilities of the network alongside Sonic Healthcare USA’s broader clinical and anatomic pathology infrastructure.
“Tempus materially strengthens the oncology dimension of our commercialisation model,” said Dr Ehab A. El-Gabry, Chief Medical Officer and Head of Companion Diagnostics at CellCarta.
“Sponsors can develop and validate a companion diagnostic at CellCarta, pursue a single-site approval strategy through our flexible and modular CDx Accelerator Model and then use an established oncology diagnostics platform to support physician access and ordering."
This connects regulatory execution with the realities of commercial launch.
The expansion reflects the growing importance of commercialisation planning within companion diagnostic programmes — for pharma companies developing targeted oncology therapies, the availability of an appropriate diagnostic test can be critical to identifying eligible patients and supporting the clinical use of a biomarker-driven treatment.
CellCarta added that it plans to further expand its Commercialization Lab Network by geography, therapeutic area and commercial capability.
The company also aims to provide sponsors with flexibility to expand beyond centralised testing through additional laboratory partners or, potentially, an in-vitro diagnostic (IVD) kit solution.
