CellCarta, a Canada-based global CRO laboratory to the biopharmaceutical industry, announced on Wednesday a strategic partnership with Sonic Healthcare USA Inc to launch the first commercial laboratory relationship in CellCarta's Lab Network strategy, designed to support commercialisation of companion diagnostics developed through CellCarta's single-site PMA CDx bridging model.
According to CellCarta, this marks an important step in its 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 US 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.
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