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Accelevir Diagnostics delivers regulatory-ready dPCR services engineered for absolute quantification of nucleic acid targets in clinical trials — overcoming the limitations of conventional methods like standard curve-dependent qPCR. Our CLIA-certified and CAP-accredited laboratory combines deep digital PCR expertise with validated workflows supporting cell therapy, gene therapy, virology, and oncology programs from IND through BLA submission.
Digital polymerase chain reaction eliminates the variability inherent in quantitative PCR standard curves by partitioning each PCR sample into thousands of independent reactions.
After endpoint PCR amplification and endpoint measurement, Poisson statistical analysis converts positive reaction counts into precise quantification of target nucleic acid molecules — no reference sample required.
For sponsors pursuing gene and cell therapy approvals, droplet digital PCR (dPCR) and related dPCR platforms provide the precise quantification regulators expect for vector titer, transgene persistence, and biodistribution endpoints.
Absolute quantification, rare-target sensitivity, and matrix tolerance for regulated bioanalysis.
From IND through BLA.
This approach delivers significant benefits for regulated bioanalysis — from absolute quantification through ultra-rare target detection.
Without calibration curves — eliminating the need for relative quantification methods, reducing inter-assay variability, and simplifying method transfer between laboratories.
Approaching 0.001% MAF under optimized conditions with sufficient input DNA, supporting earlier identification of resistance mutations and minimal residual disease monitoring. Achievable sensitivity depends on partition number, input DNA, and assay design.
Spanning four or more orders of magnitude — supporting gene therapy vector quantification from manufacturing through biodistribution.
Reliable results across challenging matrices including FFPE tissue, cell-free DNA, and complex clinical specimens.
CVs typically at or below 10% mid-range copy numbers across validated concentration ranges, supporting ICH M10 validation requirements.
A specialized partitioning approach enabling reliable detection of one target in a million molecules — critical for HIV reservoir quantification, MRD monitoring, and ultra-low-level biodistribution.
Because dPCR relies on PCR completion rather than real-time fluorescence, assays can be designed to accommodate sequence variation at primer/probe positions — particularly valuable for HIV and other RNA viruses.
Our digital PCR system supports the full spectrum of bioanalytical applications for clinical research, a broad range from pathogen quantification to rare sequence detection in oncology liquid biopsy programs.
Accelevir maintains validated digital PCR methods for HIV-1 clinical trials, including viral load monitoring, proviral DNA quantification, and transcription profiling assays. Our capabilities extend to:
We support lentivirus vector quantification and AAV programs with validated dPCR applications including:
Our dPCR gene expression capabilities extend beyond mRNA quantification to include microRNA detection — a critical capability for biomarker discovery, immune cell profiling, and liquid biopsy programs where small non-coding RNAs serve as disease indicators.
Our workflows to detect rare mutations leverage sample partitioning and amplification process optimization to achieve:
Accelevir maintains a growing portfolio of validated and pre-designed dPCR assays available for immediate deployment, reducing development timelines for sponsors working with common targets and model systems.
For novel targets or custom applications, our experienced assay development team designs and validates bespoke solutions matched to your specific program requirements.
Provirus quantification and intactness determination for reservoir-targeting therapeutic trials.
Integrated vector copy number normalized to cellular reference genes, enabling calculation of vector copies per cell, verification of integrant integrity, and longitudinal monitoring of engineered cell populations throughout treatment.
Quantifying target DNA across tissues for regulatory safety packages.
Detecting circulating tumor DNA mutations for response monitoring.
Quantifying antigen transgene expression levels, vector biodistribution in gene-based vaccine programs, and immune cell activation markers in preclinical and clinical vaccine studies.
Ensuring biologics meet purity specifications.
Supporting rare disease biomarker programs.
With small fold-change difference detection for biomarker discovery.
We design custom primers and fluorescent probes optimized for your target sequences and intended sample matrices. Our scientists optimize reaction mix composition, partition number, and input nucleic acid requirements while developing multiplexing strategies for complex analyses requiring simultaneous detection of multiple nucleic acid targets.Our expertise extends to complex linkage assays and use of modified nucleic acids to tune primer/probe specificity for SNP discrimination or tolerance depending on the use case.
We can follow ICH M10, fit-for-purpose validation, CAP/CLIA, and help clients craft an analytical qualification or validation strategy that fits their needs. Validation that follows ICH M10 requirements includes:
High-throughput implementation integrates automated liquid handling with quality control systems supporting large clinical studies. Our workflows accommodate diverse sample types while maintaining the precision required for regulatory submissions.
While sometimes, fit-for-purpose validation is all that is needed, we can deliver comprehensive method validation packages aligned with FDA and EMA expectations, including:
Accelevir’s CLIA-certified and CAP-accredited laboratory operates under externally audited quality systems meeting the demands of clinical trial bioanalysis:
Documented validation of accuracy, precision, sensitivity, specificity, and matrix effects.
For nonclinical biodistribution and toxicology support.
For clinical sample testing and reporting.
Supporting IND, BLA, and international submissions.
“Your assay development and refinement exemplifies the power of our platforms … by thoughtfully leveraging the unique precision, sensitivity, single template multiplexing, and linkage determination capabilities of digital PCR.”
“With your support of [our] therapeutic vaccine trial, we were able to quickly generate unbiased data with cutting-edge assays to evaluate the impact of a novel T cell-based therapeutic vaccine in a randomized clinical trial. Given our success working with your group, we have several planned studies testing novel interventions.”
“As an in vivo CRO, we rely heavily on strong bioanalytical partners—and working with Accelevir has truly elevated the quality of our studies. They feel like an extension of our team, consistently delivering high-quality, reliable data quickly and giving our sponsors real confidence as they move their programs forward.”
We validate digital PCR (dPCR) methods across blood (plasma, serum, PBMCs), fresh and frozen tissues, FFPE samples, and cell-free DNA. Each matrix requires optimized extraction and partitioning protocols to ensure reliable amplified target DNA detection.
While real-time PCR remains appropriate for high-abundance targets where standard-curve dependence is acceptable, digital PCR excels in several dimensions: absolute quantification without calibration curves, superior precision at low copy numbers, greater robustness to PCR inhibitors, and rare-event detection below 1% allele frequency. For regulatory submissions requiring inter-laboratory reproducibility and precise quantification, dPCR provides significant advantages regardless of target abundance.
Standard validated assays on routine sample types — including plasma, serum, and blood — typically complete within 5–7 business days from receipt of quality-acceptable samples. Complex matrices such as FFPE tissue, low-input clinical specimens, or large sample batches may require additional processing time. Contact us to discuss turnaround expectations for your specific sample type and volume.
Yes. We deliver comprehensive dPCR services method transfer packages including validation protocols, acceptance criteria, and technical support for establishing equivalent performance at sponsor or manufacturing laboratories.
Yes. We have significant experience in optimizing existing qPCR assays for multiple dPCR platforms and can help you maximize the advantages of digital PCR for your use case.
Hyperwelling is an advanced dPCR technique that increases the effective number of partitions per reaction, dramatically improving sensitivity beyond standard digital PCR performance. At Accelevir, we apply hyperwelling for applications requiring detection of extremely rare targets — such as HIV reservoir quantification, ultra-low vector copy detection in biodistribution studies, and minimal residual disease monitoring — where standard dPCR sensitivity approaches may not be sufficient. This capability enables reliable detection of targets present at frequencies as low as one in one million molecules in complex clinical matrices.
Accelevir’s scientific team is prepared to discuss your clinical program requirements and design a digital PCR service strategy aligned with your regulatory pathway.