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What If Your Biomarker Assay Could Be Trial-Ready Months Sooner?
Case Study: From RUO to Trial-Ready in Six Months
Don’t let assay development delay your clinical trial
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.
Advancing Oncology Biomarker Strategies During ASCO 2026
CellCarta supports highly customized biomarker strategies and large-scale global studies across the full biomarker continuum — from translational research through clinical development and companion diagnostic (CDx) advancement. Our broad suite of genomics services can support your clinical trial, whether you require digital PCR, quantitative PCR, next-generation sequencing, or spatial analysis.
CellCarta supports highly customized biomarker strategies and large-scale global studies across the full biomarker continuum — from translational research through clinical development and companion diagnostic (CDx) advancement. Our broad suite of genomics services can support your clinical trial, whether you require digital PCR, quantitative PCR, next-generation sequencing, or spatial analysis.
Discover the integrated strategy that delivered a validated, Phase 3 trial-ready FGFR NGS assay in under six months.
What If Your Biomarker Assay Could Be Trial-Ready Months Sooner?
Discover the integrated strategy that delivered a validated, Phase 3 trial-ready FGFR NGS assay in under six months.
Case Study: From RUO to Trial-Ready in Six Months
Don’t let assay development delay your clinical trial
PBMC Processing
Same-day PBMC processing following robust SOPs across labs in NA, EU, Australia, and China.
PBMC Processing
Same-day PBMC processing following robust SOPs across labs in NA, EU, Australia, and China.
What Our Clients Say
The Lake Forest Expertise
“CellCarta was able to present a proposal in less than a week and they were ready to contract to get kits to our sites as soon as possible. They offered expedited start up without breaking the bank on costs to get the database and lab manual ready for review and sign off faster than any other central lab I've come across.”
Lead Outsourcing Director, Biopharma
The Lake Forest Expertise
“CellCarta was extremely helpful with the data analysis: great shout out to the data analysis team! The team in MTL was super fast and super professional!”
Biopharma Partner
The Lake Forest Expertise
"CellCarta’s project managers are supportive and attentive — they coordinate with your data team, CRO/CRAs, and other vendors as needed. They don't wait for us as the sponsor to bring issues up; they bring concerns to our attention and come prepared with resolution options.”
Lead Outsourcing Director, Biopharma
What Our Clients Say
“CellCarta was able to present a proposal in less than a week and they were ready to contract to get kits to our sites as soon as possible. They offered expedited start up without breaking the bank on costs to get the database and lab manual ready for review and sign off faster than any other central lab I've come across.”
Lead Outsourcing Director, Biopharma
“CellCarta was extremely helpful with the data analysis: great shout out to the data analysis team! The team in MTL was super fast and super professional!”
Biopharma Partner
"CellCarta’s project managers are supportive and attentive — they coordinate with your data team, CRO/CRAs, and other vendors as needed. They don't wait for us as the sponsor to bring issues up; they bring concerns to our attention and come prepared with resolution options.”
Lead Outsourcing Director, Biopharma