Molecular Assay Development Tailored to Your Therapeutic Pipeline
Precision-Driven Custom Assay Solutions for Biotech and Biopharma
Accelevir provides end-to-end molecular assay development for innovators across the biotechnology, pharmaceutical, and gene therapy sectors. Our solutions are built to meet the challenges of cutting-edge therapies and high-stakes clinical research. From ultrasensitive detection to multiplex vector integrity analysis, our custom assays are engineered for precision, reproducibility, and regulatory alignment.
Whether your goals include early discovery, IND-enabling studies, or FDA submission, Accelevir is your partner in developing bespoke assays that accelerate development and enhance confidence in your data.
Core molecular assay capabilities:
- Digital PCR (dPCR) & Droplet Digital PCR (ddPCR)
- Quantitative Real-Time PCR (qPCR)
- Next-Generation Sequencing (short-read & long-read)
- SNP Genotyping, Copy Number Variation, and Mutation Detection
- Multiplex assays for proviral integrity and immune monitoring
- Isothermal amplification (LAMP/RPA)
Therapeutic focus areas:
- Cell & Gene Therapy (AAV, LV, CAR-T)
- Infectious Disease (HIV, SARS-CoV-2, viral vectors)
- Oncology (liquid biopsies, tumor mutation burden)
- Autoimmune & Rare Disease Research
End-to-End Assay Development & Validation
Fit-for-Purpose Support from Concept to Clinical Readiness
At Accelevir, we approach assay development as a lifecycle partnership. Our multidisciplinary team works with you to design assays that align with your scientific goals, target analytes, and intended regulatory pathway.
Discovery & Preclinical Applications
- Biomarker discovery and exploratory screening
- Biodistribution and vector persistence analysis
- Mechanism of action (MoA) studies and immune profiling
- High-sensitivity quantification for low-abundance targets
Clinical Development & Bioanalysis
- PK/PD quantification for nucleic acid therapeutics
- Viral shedding and immunogenicity (ADA, NAb) testing
- Longitudinal gene expression and immune monitoring
- Qualification of assays for clinical trials (GLP, CLIA)
Regulatory Submissions & Tech Transfer
- Clinical validations (CLIA, GLP, ISO 13485)
- 510(k), PMA, and companion diagnostic (CDx) support
- Kit configuration and manufacturing (RUO, IVD)
- Tech transfer to third-party labs or manufacturing partners
Molecular Platforms & Laboratory Infrastructure
Accelevir’s CLIA-certified, high-complexity laboratory is equipped with state-of-the-art instrumentation and standardized workflows to ensure data quality and scalability.
Technology suite includes:
- Bio-Rad QX200 & QXOne ddPCR Systems
- ThermoFisher QuantStudio™ 5 & 7 for qPCR
- Qiagen QIAcuity, QIAxpert, and QIAcube platforms
- Short- and long-read NGS platforms (Illumina, Oxford Nanopore)
- Beckman Coulter CytoFLEX Flow Cytometers
- Hologic Panther Fusion System
Integrated workflows:
- Automated cell isolation with RoboSep™
- PBMC processing, biobanking, and subset enrichment
- Flow cytometry for immune phenotyping and functional assays
- ELISpot, FluoroSpot, ELISA, and cytokine profiling
Why Choose Accelevir for Molecular Assay Development?
Deep Scientific Expertise | High Sensitivity Assays | Regulatory Alignment
- CLIA-Certified Environment: All assays run under rigorous SOPs with validated quality control.
- Multiplex dPCR Expertise: High-resolution insights into gene integration, vector payload integrity, and persistence.
- Custom Assay Design: Bespoke solutions tailored to unique vectors, biomarkers, and sample types.
- Preclinical CRO Collaboration: Integrated services with Noble Life Sciences for in vivo efficacy and IND-enabling studie
- Full Spectrum Immunology Support: ADA, NAb, ELISpot, cytokine assays, and immune cell function panels
- Regulatory Support: Fit-for-purpose validation for GLP, CLIA, ISO 13485, and FDA pathways
Ready to Start Your Molecular Assay Project?
Whether you need to quantify a gene therapy vector, validate an ultra-sensitive bioanalytical method, or build an IVD-ready PCR assay, Accelevir is your molecular development partner.
Contact our scientific team to schedule a discovery call. We’ll help scope your needs, align on assay requirements, and build a plan for success.
Frequently Asked Questions
What types of molecular assays can Accelevir develop?
We support PCR (qPCR, ddPCR), NGS, vector copy number assays, SNP detection, ADA/NAb testing, and more across a variety of therapeutic areas.
Do you provide assay validation for regulatory submissions?
Yes. We offer validation services that meet GLP, CLIA, and ISO 13485 standards, with documentation suitable for FDA 510(k) and PMA filings.
Can you handle complex sample matrices?
Absolutely. We routinely process plasma, CSF, tumor tissue, PBMCs, swabs, and more under validated workflows.
Do you offer tech transfer or assay manufacturing?
Yes. We can configure your assay for RUO/IVD use and transfer validated methods to external partners or manufacturing sites.
Can you integrate molecular data with immunological readouts?
Yes. We offer fully integrated services including immune phenotyping, functional cell assays, and cytokine/chemokine profiling.