Sonic Healthcare USA Announces Partnership with CellCarta to Expand Access to Companion Diagnostic Testing and Clinical Trial Services

CellCarta, a leading global CRO laboratory, announced a strategic partnership with Sonic Healthcare USA and launched its first commercial laboratory, designed to support the commercialization of companion diagnostics developed through CellCarta’s single-site PMA CDx bridging model. 

This Partnership marks a significant step toward CellCarta’s strategy to help biopharma companies that move from companion diagnostics development and regulatory approval to commercial deployment through a scalable provider-facing laboratory network. This Sonic supports commercialization by serving as the direct interface with providers and patients, helping enable order flow, customer relationships, and market access execution across target geographies. 

According to Towards Healthcare, the U.S. infectious respiratory disease diagnostics market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 2.77 billion in 2026 to approximately USD 4.65 billion by 2035, representing a compound annual growth rate (CAGR) of 5.9% from 2026 to 2035. Growth is driven by rising disease prevalence and geriatric population, persistent threats of flu and RSV, and ongoing global surveillance for infectious diseases, ensuring a steady, high volume of testing demand with increasing integration of AI in diagnostic imaging and software, which ensures more accurate and earlier diagnoses. 

Chief Executive Officer of CellCart, Dusty Tenney, stated that biopharma companies increasingly want a faster, more controlled path to companion diagnostic approval, but they also need a credible route to commercialization once that approval is secured. With Sonic as our first committed commercial laboratory partner, we are creating a bridge from single-site PMA and centralized IVD approval strategies to broader physician and patient access. 

About CellCarta 

CellCarta operates in the U.S. infectious respiratory disease diagnostics market as a specialized Contract Research Organization (CRO) rather than a direct supplier of commercial test kits. They provide biomarker testing, genomic profiling, and clinical trial support for biopharmaceutical companies developing vaccines and therapeutics for indications like influenza and tuberculosis. 

About Sonic Healthcare USA 

Sonic Healthcare Ltd is based in Sydney as the third-largest medical laboratory that holds a significant regional market across the Sunbelt, West, Southwest, and Northeast regions. Sonic’s laboratories deploy highly complex molecular testing, including multiplex PCR assays, to accurately diagnose and differentiate co-infections. 

Testing Scope processes high volumes of polymerase chain reaction (PCR) and multiplex assay tests across their hospital partnerships, regional reference laboratories, and physician networks. 

A recent report by Towards Healthcare highlights that the U.S. infectious respiratory disease diagnostics market is witnessing growth due to the fastest-growing segment of consumers and healthcare providers increasingly demanding rapid, convenient, and decentralized diagnostic solutions outside of traditional laboratories to enable immediate treatment.