CellCarta and Pillar Biosciences Accelerate FGFR NGS Assay from RUO to IUO for Global Phase 3 Oncology Trial

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June 23, 2026

Integrated collaboration completed clinical trial assay development and validation and enabled IDE and associated regulatory submissions in approximately five months.

MONTREAL, CANADA, JUNE 23, 2026 — CellCarta, a leading global CRO laboratory to the biopharmaceutical industry, today announced the successful development and clinical implementation of a customized FGFR next-generation sequencing assay in collaboration with strategic partner Pillar Biosciences for a global Phase 3 oncology clinical trial.

The collaboration addressed an urgent need for a global biopharmaceutical company seeking to replace an obsolete qPCR-based patient-selection assay without delaying the planned initiation of its late-stage clinical trial. Because at the time of development no commercially available panel offered complete coverage of the FGFR target mutations and fusions required by the clinical protocol, a custom solution was required.

CellCarta and Pillar established an integrated development model designed to move the assay rapidly from a research-use-only (RUO) configuration to an investigational-use-only (IUO), solution while simultaneously completing clinical trial assay development and validation and supporting the sponsor’s Investigational Device Exemption and associated regulatory submission activities.

The combined program moved from project initiation to clinical trial readiness in approximately five months. The accelerated timeline was enabled by early alignment among the sponsor, Pillar, and CellCarta on the intended use, required genomic coverage, specimen requirements, analytical validation strategy, regulatory documentation, data analysis, reporting, and clinical trial workflow.

Using Pillar Biosciences’ oncoReveal^® Essential and Fusion NGS assays as the foundation, the companies developed a combined solution providing the required FGFR target mutation and fusion coverage. Pillar led the assay customization and RUO-to-IUO kit-development activities and data generation for the required IDE and PSA submissions, while CellCarta developed and validated the clinical trial assay and established the quality-controlled laboratory workflow required for prospective patient-selection testing.

The project was structured around parallel development, validation, regulatory, and operational workstreams rather than a conventional sequential approach. This allowed technical findings identified during clinical validation to be addressed rapidly by the combined CellCarta and Pillar project team while regulatory documentation, laboratory implementation, personnel training, and trial-readiness activities progressed concurrently.

“Biomarker testing can become a critical-path risk when the required patient-selection assay is unavailable, obsolete, or not sufficiently comprehensive for the clinical program,” said Robin Grimwood, Senior Vice-President and General Manager of the Genomics Business Unit of CellCarta. “By bringing CellCarta and Pillar together as one integrated project team, we were able to compress activities that might traditionally occur sequentially and deliver a trial-ready NGS solution within an exceptionally aggressive Phase 3 timeline.”

The collaboration advanced the customized assay from its RUO foundation to an IUO configuration, completed the clinical trial assay validation, and generated the technical and validation documentation intended to support the IDE and associated regulatory submission process.

The assay was transferred into CellCarta’s controlled clinical laboratory environments in Antwerp, Belgium, and Naperville, United States, and operationalized to support patient testing and the sponsor’s planned first-patient enrollment timeline. The globally aligned implementation model also provides the capability to extend testing to China through CellCarta’s Jining laboratory, supporting broader global trial deployment as required.

“Late-stage precision medicine trials require more than a technically capable assay,” said Jurgen Del Favero, Vice President, Genomics Services and Innovation Strategy at CellCarta. “The assay must be fit for its intended clinical use, supported by a rigorous validation package, aligned with regulatory expectations, and operationally ready to deliver reliable results within the turnaround times required for patient enrollment. This collaboration brought those elements together from the beginning rather than treating them as separate downstream activities.”

“This program demonstrates the flexibility of Pillar’s NGS technology and the value of collaborating closely with an experienced global clinical laboratory,” said Dan Harma, Chief Commercial Officer. “By aligning our assay-development and kit capabilities with CellCarta’s clinical validation, regulatory, and operational expertise, we were able to rapidly deliver a customized solution addressing a complex set of technical and clinical trial requirements.”

The collaboration reflects a growing need among biopharmaceutical sponsors for more integrated diagnostic-development models, particularly when a biomarker assay must be customized, validated, and deployed within the fixed timelines of a late-stage clinical program.

By coordinating the technology developer, clinical laboratory, and therapeutic sponsor from the beginning, the model is designed to reduce development handoffs, identify technical and regulatory risks earlier, and create a more direct path from assay concept to prospective patient testing.

CellCarta and Pillar expect the collaborative model to support future precision medicine programs in which commercially available assays do not provide the biomarker coverage, specimen compatibility, regulatory readiness, or operational flexibility required for clinical trial use.

To learn more about CellCarta’s genomics and clinical trial assay-development capabilities, visit cellcarta.com.

About CellCarta

CellCarta is a leading global CRO laboratory to the biopharmaceutical industry. With CAP accreditations and CLIA certifications for specific testing methods and facilities in Canada, the United States, Belgium, Australia, and China, CellCarta provides a wide range of biomarker testing services and customized solutions to world-renowned pharmaceutical companies.

By integrating analytical platforms in immunology, histopathology, proteomics, and genomics, along with sample management and logistics services, CellCarta supports the entire drug-development cycle from discovery to late-stage clinical trials.

Visit cellcarta.com and connect with CellCarta on LinkedIn and X.

About Pillar Biosciences

Pillar Biosciences is a precision medicine company focused on developing and delivering next-generation sequencing solutions for clinical and research applications. Pillar’s proprietary technologies are designed to enable laboratories to perform targeted genomic testing with efficient workflows and limited sample input.

The company’s oncoReveal® portfolio supports the detection of clinically relevant genomic alterations, including single-nucleotide variants, insertions and deletions, copy-number alterations, and gene fusions.

Visit pillarbiosci.com for more information.