CDx Development Services

Our CDx solution takes a modular approach, allowing you to engage CellCarta at any point of entry in your product lifecycle. Wherever your program may be, our CDx services are highly flexible, so we can help map out the most efficient path forward while integrating seamlessly into your existing program timeline.

That said, earlier engagement can yield the greatest strategic advantage. Teams that involve us during the discovery phase benefit from platform-agnostic assay design, fit-for-purpose development, and a regulatory strategy shaped from the outset to support efficient approval and eventual bridging to scalable kitted deployment. Wherever you are in the process, we can assess your current position and recommend the most direct route to your next milestone.

Traditional CDx development is split into two models, each with their advantages and limitations. Notably, the single-site model creates a bottleneck for commercial deployment and scalability, while the decentralized model can introduce regulatory challenges that delay their time-to-market. To address these limitations, CellCarta’s hybrid CDx Accelerator Model uses a phased approach with risk-managed progression and built-in decision gates at each stage, allowing teams that require more flexibility to benefit (e.g., cost constraints).

With platform-agnostic testing across multiple modalities, teams avoid the lock-in that slows conventional CDx development programs. Our CDx services model is designed to accelerate market penetration while bringing your CDx to submission earlier.

CellCarta supports platform-agnostic CDx services across major diagnostic technologies, including IHC/IF, ISH/FISH, digital pathology, AI-enabled image analysis, targeted NGS, qPCR, dPCR, and other molecular workflows. For genomic CDx programs, we can support tissue- and blood-based testing strategies designed to detect clinically relevant alterations such as mutations, fusions, copy-number changes, and other biomarker-defined signatures, depending on the assay and intended use. This flexibility allows sponsors to match the diagnostic technology to the biomarker, sample type, clinical decision, and regulatory pathway rather than forcing the program into a single platform too early. Whatever your program requires, we have the technical infrastructure and scientific expertise to deliver.

Studies suggest that approximately 75-90% of clinical trials will fail before approval is reached, particularly in phase II and III (as reported in BIO, Informa Pharma Intelligence, QLS, Clinical Development Success Rates 2011-2020). CellCarta's phased model is specifically designed to de-risk your CDx development program at every stage. Rather than committing to a single platform and full-scale commercialization upfront, our approach uses structured decision gates that let you evaluate performance data, adjust your biomarker strategy, and preserve optionality as your program evolves at a minimal cost.

Our staged model allows studies to benefit at whatever phase of development they are. This means your team can make informed decisions based on real data rather than assumptions. Our CDx solutions also adapt to evolving targets and indications, so if your clinical program shifts direction, your companion diagnostic strategy can shift without starting over.

CDx regulatory approval requires demonstrating that your assay is analytically validated, clinically meaningful, and manufactured under a controlled quality system. In the US, the FDA typically requires a  submission that includes analytical performance data, clinical validation evidence linking the biomarker to therapeutic response, and documentation of design controls and manufacturing processes under an ISO 13485-compliant quality system. The submission pathway depends on the device classification and similarities to existing on-market devices, and may include a 510(k) Pathway, De Novo Classification, or Premarket Approval (PMA). CellCarta’s regulatory experts can discuss these pathways with you to plan and execute the optimal pathway for your IVD.

In Europe, the EU IVDR imposes its own requirements for clinical evidence, performance evaluation, and conformity assessment. CellCarta's dedicated regulatory team provides guidance f pathways, supporting CDx development from assay validation and design controls through performance studies and submission preparation.