Case Study: From RUO to Trial-Ready in Six Months

July 21, 2026

When a global biopharmaceutical company needed to replace an obsolete qPCR-based patient-selection assay for a Phase 3 cancer trial, speed was essential, but speed alone was not sufficient.

CellCarta and Pillar Biosciences responded with an integrated development model that ran assay design, clinical validation, regulatory documentation, and laboratory implementation as parallel workstreams rather than sequential ones.

The result: a validated, trial-ready FGFR NGS patient-selection assay delivered in less than six months! Cutting the standard 10–12 month process nearly in half and keeping the sponsor’s first-patient enrollment timeline on track.

Read the full Case Study!

Case Study: From RUO to Trial-Ready in Six Months

Case Study: From RUO to Trial-Ready in Six Months

July 21, 2026

When a global biopharmaceutical company needed to replace an obsolete qPCR-based patient-selection assay for a Phase 3 cancer trial, speed was essential, but speed alone was not sufficient.

CellCarta and Pillar Biosciences responded with an integrated development model that ran assay design, clinical validation, regulatory documentation, and laboratory implementation as parallel workstreams rather than sequential ones.

The result: a validated, trial-ready FGFR NGS patient-selection assay delivered in less than six months! Cutting the standard 10–12 month process nearly in half and keeping the sponsor’s first-patient enrollment timeline on track.

Read the full Case Study!

Case Study: From RUO to Trial-Ready in Six Months

Case Study: Delivering Clinical-Grade Interpretable Findings from Hyperplex Spatial Biology

July 17, 2026

The challenge: Hyperplex data eliminates inter-slide variability, but introduces it's own challenges

By reading dozens of markers from a single slide, spatial biology approaches minimize tissue use and remove slide-to-slide variability. But it comes with its own challenges: huge data volumes, and the requirement for stringent phenotyping consistency and analytical rigor to make accurate, actionable conclusions.

The platform: Built on the COMET

How the COMET works: an integrated staining and scanning system analyzing up to 40 markers on a single slide through iterative stain-image-elute cycles, built for the standardized, documented protocols clinical trial contexts demand.

The assay was developed and validated for accuracy, sensitivity, specificity, and cross-site concordance between CellCarta's labs in Lake Forest, California and Antwerp, Belgium.

The study: Complete responder vs non-responder dataset

In a 20-plex hyperplex analysis of tissue samples from patients with muscle-invasive bladder cancer treated with neo-adjuvant immunotherapy, CellCarta's clinical-grade COMET workflow highlighted distinct differences in immune composition, spatial proximity, and tissue organization between an immunotherapy responder and a non-responder, all from a single slide per patient.

  1. Phenotype composition how immune, stromal, and tumor proportions differed between the two cases
  2. Spatial distance, co-localization and niche analysis
  3. What it means for IO programs how tissue organization, not just cell counts, reflects response
  4. How we build global assays for comparable results, regardless of data collection location
  5. The clinical-grade, platform agnostic workflow that turns hyperplex image data into reliable, interpretable biological findings

From early-stage biotechs to established biopharma, understanding why some patients respond better than others is essential.

Read the full case study!

Case Study: Delivering Clinical-Grade Interpretable Findings from Hyperplex Spatial Biology

July 17, 2026

The challenge: Hyperplex data eliminates inter-slide variability, but introduces it's own challenges

By reading dozens of markers from a single slide, spatial biology approaches minimize tissue use and remove slide-to-slide variability. But it comes with its own challenges: huge data volumes, and the requirement for stringent phenotyping consistency and analytical rigor to make accurate, actionable conclusions.

The platform: Built on the COMET

How the COMET works: an integrated staining and scanning system analyzing up to 40 markers on a single slide through iterative stain-image-elute cycles, built for the standardized, documented protocols clinical trial contexts demand.

The assay was developed and validated for accuracy, sensitivity, specificity, and cross-site concordance between CellCarta's labs in Lake Forest, California and Antwerp, Belgium.

The study: Complete responder vs non-responder dataset

In a 20-plex hyperplex analysis of tissue samples from patients with muscle-invasive bladder cancer treated with neo-adjuvant immunotherapy, CellCarta's clinical-grade COMET workflow highlighted distinct differences in immune composition, spatial proximity, and tissue organization between an immunotherapy responder and a non-responder, all from a single slide per patient.

  1. Phenotype composition how immune, stromal, and tumor proportions differed between the two cases
  2. Spatial distance, co-localization and niche analysis
  3. What it means for IO programs how tissue organization, not just cell counts, reflects response
  4. How we build global assays for comparable results, regardless of data collection location
  5. The clinical-grade, platform agnostic workflow that turns hyperplex image data into reliable, interpretable biological findings

From early-stage biotechs to established biopharma, understanding why some patients respond better than others is essential.

Read the full case study!

Improved whole transcriptome sequencing for challenging clinical samples: A streamlined alternative to targeted RNA-seq

June 15, 2026

  • Using the Watchmaker RNA Library Prep with Polaris Depletion, we evaluated whole transcriptome sequencing in challenging clinical sample types.
  • Explore our case study to discover the Watchmaker workflow’s advantages over traditional targeted RNA sequencing approaches to support a vast range of clinical and translational applications.

Improved whole transcriptome sequencing for challenging clinical samples: A streamlined alternative to targeted RNA-seq

Improved whole transcriptome sequencing for challenging clinical samples: A streamlined alternative to targeted RNA-seq

June 15, 2026

  • Using the Watchmaker RNA Library Prep with Polaris Depletion, we evaluated whole transcriptome sequencing in challenging clinical sample types.
  • Explore our case study to discover the Watchmaker workflow’s advantages over traditional targeted RNA sequencing approaches to support a vast range of clinical and translational applications.

Improved whole transcriptome sequencing for challenging clinical samples: A streamlined alternative to targeted RNA-seq

Accurately Predict Immune Checkpoint Inhibition Response Using Only RNA-Seq Data

June 27, 2023

  • Discover how we have improved response predictions for immune checkpoint inhibitor (ICI) therapies.
  • Explore our unique computational pipeline that defines multiple characteristics (eTMB, MSI, and more) directly from the RNA-sequencing profile of a tumor.

Accurately Predict Immune Checkpoint Inhibition Response Using Only RNA-Seq Data

June 27, 2023

  • Discover how we have improved response predictions for immune checkpoint inhibitor (ICI) therapies.
  • Explore our unique computational pipeline that defines multiple characteristics (eTMB, MSI, and more) directly from the RNA-sequencing profile of a tumor.

State-of-the-Art Digital Pathology | CellCarta

The beauty of better results with digital assays and AI-driven image analysis!

State-of-the-Art Digital Pathology

Our 21 CFR-part 11 compliant digital image analysis workflow ensures high-quality clinical insights. We provide detailed H&E and IHC/IF/ISH image analysis using advanced software with AI capabilities to support your clinical studies.

Discover the art of digital analysis!

CellCarta’s digital pathology expertise combines a meticulous digital assay workflow with comprehensive image analysis.

Download the resource

Digital image analysis workflow

As a global CRO, we prioritize your study goals and clinical trial needs above all else. We aim to provide you with easy, accessible, and comprehensive technologies spanning a multitude of therapeutic areas.

Discover our range of services in immunology, proteomics, genomics, as well as related ML/AI and sample logistics services.

State-of-the-Art Digital Pathology | CellCarta

The beauty of better results with digital assays and AI-driven image analysis!

State-of-the-Art Digital Pathology

Our 21 CFR-part 11 compliant digital image analysis workflow ensures high-quality clinical insights. We provide detailed H&E and IHC/IF/ISH image analysis using advanced software with AI capabilities to support your clinical studies.

Discover the art of digital analysis!

CellCarta’s digital pathology expertise combines a meticulous digital assay workflow with comprehensive image analysis.

Download the resource

Digital image analysis workflow

As a global CRO, we prioritize your study goals and clinical trial needs above all else. We aim to provide you with easy, accessible, and comprehensive technologies spanning a multitude of therapeutic areas.

Discover our range of services in immunology, proteomics, genomics, as well as related ML/AI and sample logistics services.