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Accelevir Diagnostics provides specialized digital PCR (dPCR/ddPCR) and quantitative PCR (qPCR) assay development for gene therapy, cell therapy, and infectious disease programs. Our CLIA-certified laboratory delivers regulatory-ready, GLP-compliant molecular assays tailored to your targets, matrices, and compliance requirements.
Our laboratory has operated droplet-based digital PCR platforms continuously since the original RainDance systems, evolving alongside today's commercial ddPCR technologies.
This long history translates into unmatched practical expertise in PCR technology, assay design, optimization, and validation.
A CLIA-certified laboratory provides regulatory-ready, GLP-compliant molecular assays tailored to your targets, matrices, and compliance requirements.
Continuous droplet-based dPCR experience since the original RainDance systems.
Decades of dPCR depth.
PCR platform and target-specific selection directly impact regulatory pathways, data quality, and development timelines. qPCR offers proven high-throughput workflows with a broad dynamic range, and digital PCR (dPCR) provides absolute quantification without standard curves, enabling higher-precision readouts for rare-target measurements.
For gene therapy and cell therapy applications, FDA expectations increasingly favor absolute quantitation methods for applications such as genome determination. Platform selection must balance sensitivity, regulatory expectations, cost, and turnaround times. Specifically for clinical trial bioanalysis, the ICH M10 bioanalytical method validation guidance provides additional requirements applicable to both qPCR and dPCR methods.
Strategic technology selection balances sensitivity requirements and regulatory endpoints against cost and timeline implications, which differ substantially across platforms.
Our droplet digital PCR capabilities support high precision of nucleic acids without reference standards or the need for calibration curves. Key offerings include:
Our real-time PCR platform delivers cost-effective, high-throughput applications requiring a wide dynamic range across 6–8 log10 orders of magnitude:
Understanding the key differences between these platforms guides optimal technology selection:
Digital PCR delivers absolute quantification via Poisson statistics without standard curve requirements. qPCR relies on calibration curves or reference controls.
dPCR reliably detects rare targets approaching fractional abundance near 0.1% under optimized conditions.
Enabling liquid biopsy applications and minimal residual disease (MRD) monitoring. qPCR typically shows reduced reliability below 1–5% VAF without enrichment steps.
qPCR spans a broad range of 6–8 log10 for target molecules. Digital PCR covers approximately 4–5 log10 before dilution is required due to partition saturation.
qPCR supports rapid high-throughput workflows and processes 96–384 samples in under 2 hours. dPCR requires additional partitioning steps and lower batch throughput.
Partitioning in dPCR isolates individual PCR reactions from potential inhibitors, maintaining PCR efficiency in complex matrices. qPCR experiments show greater sensitivity to matrix effects affecting reaction efficiency.
qPCR has lower per-sample consumable and instrument costs. dPCR carries higher costs, justified by precision at low copy numbers and absolute quantification capabilities and higher precision at low copy numbers.
Both platforms meet ICH Q2(R2) validation requirements when properly validated. dPCR is increasingly preferred for vector genome quantification in IND and BLA submissions.
We evaluate target abundance, sample matrix complexity, regulatory requirements, and throughput needs to recommend an optimal platform.
Our molecular team leverages its assay expertise to support the design of primer/probe sets that ensure primer efficiency, specificity, and multiplexing compatibility on the selected platform.
Compliant validation encompasses accuracy, precision, linearity, LOD/LOQ, and specificity testing across relevant matrices.
Vector genome quantification, biodistribution studies, viral shedding for precise quantification, rare mutation detection, minimal residual disease, and liquid biopsy applications.
High throughput pathogen detection, gene expression studies, bacterial load assessment, and screening workflows that consider broad dynamic range and cost efficiency decisions.
Both platforms support on and off-target analysis. dPCR provides higher sensitivity for low-abundance targets and small fold changes in editing efficiency.
dPCR enables detection of rare variants in cell-free DNA (cfDNA) at concentrations below reliable qPCR detection limits.
Accelevir is a CLIA-certified Laboratory and deploys its broad expertise to support Fit-for-Purpose biomarker and assay development strategies. Our team has supported >100 studies across gene therapy, oncology, cell therapy, and infectious disease programs.
As an early adopter of ddPCR and advisor to commercial instrument companies on ddPCR and dPCR applications, Accelevir is best in class with deep competency and capabilities:
Single-source guidance and support for both qPCR and ddPCR platforms to ensure sample efficiency, consistency, and cost effectiveness.
Assays designed and validated with submission readiness in mind and early consideration of key factors to save time and downstream cost.
Custom assay design and optimization are typically completed in weeks, with accelerated options using pre-validated panels.
Dedicated expertise in vector quantification, viral load assays, and immune monitoring applications within virology, immunology, and emerging therapy applications.
Patient form recommendations are aligned to scientific need, regulatory expectations, and budget.
Early adopters of ddPCR and advisors to commercial instrument companies on dPCR applications.
"Your assay development expertise was invaluable for the early selection of the right platform to achieve the required precision and sensitivity, which was achieved by digital PCR for our programs."
"Accelevir has consistently delivered high quality, reliable data and hands-on collaborative troubleshooting."
"Their support enabled rapid generation of unbiased data in a randomized T-cell therapy clinical trial."
Choose digital PCR when absolute quantification, low target abundance, inhibitor tolerance, or high precision is required. qPCR is optimal for high-throughput or cost-sensitive applications.
Yes. We routinely transfer validated qPCR assays to dPCR platforms while maintaining primer/probe sequences where feasible, optimizing partitioning conditions, and performing full revalidation.
Standard qPCR assay design and optimization requires approximately 2–4 weeks, with full analytical validation adding 4–6 weeks. dPCR programs typically require an additional 1–2 weeks for partitioning optimization and platform-specific validation. Complex multiplex assays or challenging matrices may extend these timelines — we recommend a conversation to align assumptions and timeline estimates.
Partner with Accelevir for fit-for-purpose digital PCR and qPCR assays backed by decades of dPCR expertise. Our team will help you select the right platform and validate it for your regulatory pathway.