End-to-End Molecular Diagnostic Assay Development Services
- CLIA-certified lab with expertise in rare and low-abundance target detection
- Custom solutions for RUO, IUO, and CDx applications
- From assay concept through validation, scale-up, and commercialization
With expertise across multiple platforms and assay formats, Accelevir supports full-cycle molecular diagnostic development, including assay design, optimization, regulatory validation, pilot production, and scale-up. Our cross-functional teams bring deep experience in oncology, infectious diseases, immunology, and gene therapy.
Your Molecular Diagnostic Development Partner
Accelevir partners with diagnostics developers, pharmaceutical sponsors, and biotech startups to create reliable, reproducible molecular assays that meet the highest standards for precision, sensitivity, and compliance.
We support:
- Research Use Only (RUO) workflows
- Investigational Use Only (IUO) development
- Companion Diagnostics (CDx) development and biomarker integration
We work closely with each partner to:
- Define assay performance parameters and target goals
- Select optimal technologies and reagents
- Align workflows with regulatory milestones
- Ensure reproducibility across sample types and batches
Assay Design & Development Services
Our molecular development team provides end-to-end technical and scientific services:
- Custom assay design: Primer/probe sequences, detection chemistries, and platform matching
- Assay optimization: Temperature gradients, cycling protocols, target amplification
- Formulation support: Lyophilization, buffer systems, stabilization
- Freeze-drying optimization: Shelf temperature profiles, rehydration validation
- Multiplexing: Design of multi-target assays for improved throughput and data richness
- Assay format conversion: Adaptation for PCR, LAMP, iNAAT, ddPCR, or NGS platforms
Every assay is customized to meet analytical performance and real-world clinical utility goals.
Supported Assay Technologies
We build assays for a wide array of platforms and molecular tools:
- qPCR, RT-PCR, and digital PCR (ddPCR)
- Next-generation sequencing (NGS), including full-length viral genome mapping
- Isothermal amplification platforms (LAMP, RPA)
- CRISPR-based diagnostics (Cas12, Cas13 detection workflows)
- Microarrays for multiplex genomic profiling
- Biosensor integrations for point-of-care use
Assays can be designed for automated workflows, high-throughput systems, or low-volume specialty testing.
Validation & Regulatory Compliance
Accelevir ensures each assay meets industry standards and regulatory readiness through:
- Method validation: Accuracy, precision, LOD, LOQ, specificity, reproducibility
- Bridging and comparability studies for CDx and IUO transfers
- Platform transferability: Validation for multiple labs or third-party use
- GLP/CLIA validation pathways aligned to FDA and ISO requirements
- Cut point analysis and matrix effects testing for companion diagnostics
We support documentation and reporting for:
- FDA EUA, 510(k), and BLA pathways
- CE-IVD certification
- Pre-submission consultation
Manufacturing & Scale-Up
We offer flexible assay manufacturing from pilot scale to full commercialization:
- Small-batch pilot runs for feasibility and QC
- Full-scale production in lyophilized, air-dried, or liquid reagent kits
- Lot release testing and QA documentation
- Custom barcoding, vialing, and labeling
- Automated robotic sample prep integration
Regulatory and Quality Support
Our in-house quality systems align to:
- ISO 13485 and ISO 17025 standards
- CLIA-certified high complexity testing
- FDA guidance for RUO/IUO/CDx pathways
We provide:
- Pre-market regulatory consulting
- Risk analysis and design input documentation
- Submission-ready validation reports
- Ongoing QA/QC tracking and compliance support
OEM and Commercial Supply Programs
Accelevir offers white label and OEM solutions for molecular assay development:
- Commercial-scale reagent and kit manufacturing
- Branding and kitting for distribution partners
- Packaging and labeling for private-label customers
- Strategic consultation on go-to-market launch readiness
Diagnostic Kit Assembly Services
- Custom kitting for PCR, NGS, or isothermal assay platforms
- Component sourcing and packaging to ISO and GMP standards
- Digital integration tools for sample tracking and data management
- Compose app interface tools for regulated diagnostics
Applications & Use Cases
- Infectious disease detection (HIV, HBV, HCV, SARS-CoV-2, etc.)
- Genomic and somatic mutation detection for cancer diagnostics
- Gene therapy vector quantitation and integration assays
- Pharmacogenomics and biomarker-based patient stratification
- Food safety and environmental testing assays
Project Management & Collaboration
Every Accelevir engagement includes:
- Dedicated scientific project manager
- Weekly or milestone-driven status calls
- Transparent project planning with Gantt tracking
- Customizable deliverable timelines and feedback loops
Our client relationships are high-touch, science-first, and solution-oriented.
Why Partner with Accelevir
- Full regulatory alignment and compliance infrastructure
- Deep technical experience in virology, immunology, and gene therapy
- Rapid development timelines and agile team integration
- A collaborative, science-first culture grounded in high precision assay execution
Ready to Start Your Assay Project?
Frequently Asked Questions
Do you offer assay transfer and technology migration?
Yes. We can transfer assays between platforms (e.g., qPCR to ddPCR) or between labs, providing documentation and validation.
What technologies do you use most often?
We frequently develop assays using ddPCR (Bio-Rad QX200, QIAcuity), qPCR (QuantStudio), and NGS, alongside immunoassays and sequencing.
Can Accelevir support global distribution of my kit?
Yes. We offer OEM production, lot release testing, and packaging support for international kit distribution.
How do you approach regulatory submissions?
We provide pre-submission planning, design inputs, and validation studies to support FDA, CE-IVD, and global filings.