C2i Genomics

C2i Genomics is a cancer diagnostics company whose technology applies whole-genome sequencing (WGS) and machine-learning pattern recognition to circulating tumor DNA (ctDNA) in blood in order to detect and quantify minimal residual disease (MRD), recurrence and treatment response across solid tumors. Rather than tracking a pre-selected panel of mutations, the approach builds a personalized tumor "fingerprint" comprising thousands of patient-specific mutations, derived by sequencing tumor tissue (formalin-fixed paraffin embedded) alongside a germline reference (buffy coat), and then compares subsequent plasma samples against a baseline result to report an estimated tumor fraction and a Detected / Not Detected result.

The company's original commercial offering was the cloud-based C2-Intelligence Platform and the C2inform MRD diagnostic, provided as a service to pharmaceutical and diagnostic organizations and clinical partners, with the platform described as GDPR- and HIPAA-compliant and deployable locally to return insights in roughly one to two weeks. Following the acquisition by Veracyte, the technology is presented as the TrueMRD platform, which requires a single tube of blood (under 4 ml of plasma) and is positioned to detect recurrence earlier than imaging. TrueMRD is being validated across multiple tumor types, including through the Gustave Roussy-run Phase 3 UMBRELLA trial (non-small cell lung, colorectal, pancreatic cancers and soft tissue sarcomas, evaluating pre-emptive immunotherapy in MRD-positive patients) and the Phase 3 multicenter TOMBOLA trial in Denmark in muscle-invasive bladder cancer. A muscle-invasive bladder cancer MRD test is the first application, with a launch expected in 2026, and clinical validation data in that indication published in European Urology.

Founding story

The company's technology originated in research conducted by Asaf Zviran at the New York Genome Center and Weill Cornell Medicine, together with Dan Landau, a core faculty member at the New York Genome Center and assistant professor of medicine at Weill Cornell Medicine, who became scientific co-founder and a member of the scientific advisory board. The proof-of-concept work, supported by a 2017 grant from The Mark Foundation for Cancer Research and validated in longitudinal clinical cohorts with cancer centers in New York and Boston, was published in Nature Medicine. Zviran served as co-founder, CEO and chief scientific officer; the company subsequently added Boris Oklander as chief technology officer and Ezra Sofer as general manager and chief financial officer.

Business model

C2i Genomics provided cloud-based cancer diagnostic services, selling MRD detection and monitoring to pharmaceutical and diagnostic organizations as well as clinical and research institutions, with the analysis platform deployable locally at partner sites. Following the acquisition, the TrueMRD platform is being commercialized as clinical laboratory tests, beginning with a muscle-invasive bladder cancer MRD test available to order in the US.

Revenue derives from cancer diagnostic testing services and platform-based analysis supplied to pharmaceutical and diagnostic customers and clinical partners for clinical care and drug-development research.

Traction

Validation has been carried out in longitudinal clinical cohorts with New York and Boston cancer centers, with results published in Nature Medicine and bladder cancer clinical validation data published in European Urology. The platform has been deployed for clinical and drug-development research at the National Cancer Center of Singapore, Aarhus University Hospital, NYU Langone Health and Lausanne University Hospital, and is being evaluated in the Phase 3 UMBRELLA and TOMBOLA trials. The C2inform diagnostic received CE marking and launched in Europe in 2022.

Latest developments

Veracyte announced in January 2024 its plan to acquire C2i Genomics for up to $95 million, with the first application of the technology being a muscle-invasive bladder cancer MRD test. The technology is now marketed as the TrueMRD platform; a muscle-invasive bladder cancer MRD test is described as available to order in the US, with a launch expected in 2026, and further indications planned.