CellCarta объединилась с Tempus для ускорения коммерциализации онкологических тестов в США

CellCarta adds Tempus to CDx Commercialization Lab Network Tempus joins as a second commercial laboratory partnership to support oncology-focused access within CellCarta’s CDx Accelerator Model 12 Aug 2026 CellCarta has announced a strategic collaboration with Tempus AI, Inc., where CellCarta will include Tempus in its CDx Commercialization Lab Network as the network’s second commercial laboratory partner, strengthening oncology-focused companion diagnostics offerings to biopharma sponsors. CellCarta launched its CDx Commercialization Lab Network to address a common gap in companion diagnostic programs: securing regulatory approval does not by itself create the commercial infrastructure required for physicians to order a test and for patients to access it. The network connects CellCarta’s development, regulatory, and testing capabilities with commercial laboratory partners that have established provider relationships and ordering channels. Within the CellCarta network, the collaboration gives biopharma sponsors a more direct route from companion diagnostic development and regulatory approval to commercial use in U.S. oncology practice. CellCarta develops and validates the CDx, generates the analytical and clinical evidence package, supports regulatory submissions, and performs centralized immunohistochemistry (IHC) and tissue-based testing. For sponsors within the CellCarta CDx Commercialization Lab Network, Tempus will support provider test ordering through Tempus Hub, routing sample testing to CellCarta and transmitting results back to ordering healthcare providers. Tempus joins Sonic Healthcare USA as the second member of CellCarta’s CDx Commercialization Lab Network, expanding the network’s specialized oncology capabilities alongside Sonic’s broad clinical and anatomic pathology reach across multiple disease areas. The Lab Network is part of CellCarta’s CDx Accelerator Model, a flexible and modular framework organized around four stages: Build, Validate, Launch, and Transfer. Sponsors can engage CellCarta at the stage that fits their program — from assay development and validation through clinical deployment and regulatory submission. Following approval, CellCarta activates its Commercialization Lab Network partners, such as Tempus and Sonic, to support commercial launch strategies. CellCarta intends to continue expanding the network by geography, therapeutic area, and commercial capability. The company’s objective is to give sponsors multiple pathways for launching centralized companion diagnostics while retaining flexibility for later expansion through additional laboratories or an IVD kitted solution. “Tempus materially strengthens the oncology dimension of our commercialization model,” said Ehab A. El-Gabry, MD, 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.” “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,” said Christopher Ung, Chief Scientific Business Officer of CellCarta. “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.” Want the latest science news straight to your inbox? Become a SelectScience member for free today>> Tags Frequently asked questions Show frequently asked questions How does the CellCarta and Tempus AI collaboration enhance commercialization of oncology companion diagnostics in the U.S.? CellCarta’s collaboration with Tempus AI integrates Tempus into the CDx Commercialization Lab Network as the second commercial laboratory partner. CellCarta manages CDx development, validation, evidence generation, regulatory submissions, and centralized IHC and tissue testing, while Tempus supports provider test ordering via Tempus Hub, routes samples to CellCarta, and returns results to oncologists, streamlining commercial use in U.S. oncology practice. What role does the CellCarta CDx Commercialization Lab Network play in biopharma companion diagnostic strategies? The CellCarta CDx Commercialization Lab Network connects CellCarta’s development, regulatory, and testing capabilities with commercial labs like Tempus and Sonic Healthcare USA. It offers biopharma sponsors a direct route from assay development and validation through regulatory approval to commercial launch, focusing on oncology and broader disease areas, while maintaining flexibility for later expansion through additional laboratories or an IVD kitted solution. What is CellCarta’s CDx Accelerator Model and how does it support single-site companion diagnostic approvals? CellCarta’s CDx Accelerator Model is a flexible, modular framework with four stages: Build, Validate, Launch, and Transfer. Sponsors can engage at any stage, from assay development and validation to clinical deployment and regulatory submission. The model supports single-site approval strategies, after which CellCarta activates Commercialization Lab Network partners, such as Tempus and Sonic, to execute commercial launch strategies and connect regulatory execution with real-world physician access.