Strategic Collaboration Expands Commercial Access to Oncology Companion Diagnostics

CellCarta, a global CRO laboratory serving the biopharmaceutical industry, has announced a strategic collaboration with Tempus AI to broaden access to companion diagnostics (CDx) in oncology. Tempus becomes the second commercial laboratory partner in CellCarta’s CDx Commercialization Lab Network, contributing its oncology expertise to the company’s CDx Accelerator Model. The agreement aims to give biopharma sponsors a more direct path from diagnostic development and regulatory approval to clinical use in the United States. Tempus joins Sonic Healthcare USA, complementing Sonic’s broad clinical and anatomic pathology reach across multiple disease areas

Within the model, CellCarta develops and validates the CDx, generates the analytical and clinical evidence package, supports regulatory submissions, and performs centralized immunohistochemistry (IHC) and other tissue-based testing. For sponsors in the network, Tempus will enable provider test ordering through Tempus Hub, route sample testing to CellCarta, and transmit results back to ordering healthcare providers. This framework is intended to preserve continuity from development and approval through testing while leveraging established oncology ordering channels.

Image: Tempus becomes the second commercial laboratory partner in CellCarta’s CDx Commercialization Lab Network, contributing its oncology expertise to the company’s CDx Accelerator Model

The Lab Network operates within CellCarta’s CDx Accelerator Model, a flexible, modular framework organized around four stages: Build, Validate, Launch, and Transfer. Sponsors can enter at the stage that fits their program, from assay development and validation through clinical deployment and regulatory submission. Following approval, CellCarta activates its commercialization partners, such as Tempus and Sonic, to support commercial launch strategies.

The initiative was created to address a common gap in CDx programs: regulatory approval alone does not create the commercial infrastructure required for physicians to order tests and for patients to access them. CellCarta plans to expand the network by geography, therapeutic area, and commercial capability, with an objective of offering multiple pathways for launching centralized CDx and flexibility for later expansion through additional laboratories or an in vitro diagnostic (IVD) kitted solution.

“Tempus materially strengthens the oncology dimension of our commercialization model. 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,” said Ehab A. El-Gabry, MD, Chief Medical Officer and Head of Companion Diagnostics at CellCarta.

“Biopharma sponsors should not have to choose between the speed and control of a centralized CDx strategy and a credible path to physicians and patients. Adding Tempus to our network creates a powerful route into U.S. oncology practice. It gives sponsors a practical commercialization channel from a company that oncologists already know and use, while CellCarta maintains continuity from development and regulatory approval through testing,” said Christopher Ung, Chief Scientific Business Officer of CellCarta.

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