At CD BioSciences we offer a specialized "Assay Development Support" service tailored to research- and pre-clinical-stage diagnostic development focused on the human herpesvirus (HHV) family. Our solution is designed for pharmaceutical biotech companies, academic research institutions, and translational science groups seeking robust, reproducible, and regulatory-minded assay development workflows for HHV-related biomarkers, viral proteins, nucleic acids, or immune responses.
Background: Why HHV-Focused Assay Development Matters
The human herpesvirus family (which includes viruses such as Herpes Simplex Virus 1 (HSV-1), Human Cytomegalovirus (HCMV), Kaposi's Sarcoma‑associated Herpesvirus (KSHV/HHV-8), and others) is characterized by complex biology: lifelong latent infection, periodic reactivation, and a wide spectrum of disease manifestations from asymptomatic carriage to severe immunocompromised-host pathology.
For diagnostic assay development, this means additional challenges: choosing the right analyte (viral nucleic acid vs antigen vs immune biomarker), addressing latency vs lytic phases, dealing with low viral burden or latent reservoirs, ensuring high specificity across closely related herpesvirus species, and designing robust quantitative read-outs that are fit-for-purpose in research and pre-clinical contexts.
Published literature underscores these challenges: for example, consensus PCR assays across multiple herpesvirus sub-families were only recently developed to achieve broad detection performance. In serologic and antigen-capture contexts, development of reliable immunoassays for KSHV/HHV-8 has been historically non-trivial. Given this scientific complexity, a dedicated specialist partner for HHV assay development is a strategic advantage for organizations advancing diagnostic, therapeutic, or translational HHV programmes.
What We Offer: Assay Development Support for HHV
At CD BioSciences we structure our Assay Development Support service around three major phases: Assay Concept & Design, Assay Build & Optimization, and Assay Transfer & Qualification. We guide clients through each phase with HHV-specific experience, documentation standardisation, and quality-conscious practices.
a) Assay Concept & Design
- Collaborative consultation on selection of target analyte: viral DNA/RNA, viral antigen, host immune biomarker, latency-marker vs lytic-marker.
- Review of the relevant HHV species/subtype (e.g., HSV-1, HSV-2, HCMV, HHV-6A/B, HHV-7, EBV, KSHV) and analysis of assay cross-reactivity risks.
- Definition of performance goals (sensitivity, specificity, dynamic range, reproducibility, limit-of-detection) aligned with the client's research-stage or pre-clinical use-case.
- Development of assay architecture: molecular detection (qPCR, ddPCR, NGS), immunoassay (ELISA, time-resolved fluorescence, immunofluorescence), antigen capture, host biomarker panels. For example, modern DNA-based HHV detection technologies are increasingly recognised as "gold standard" in research contexts.
- Documentation of assay development plan including timeline, milestone gates, risk-mitigation steps, raw material sourcing (antibodies, reference standards, control viral stocks) and regulatory-grade supportive documentation (e.g., certificate of analysis for reagents, traceability logs, calibration records).
b) Assay Build & Optimization
- Procurement and qualification of control materials: e.g., HHV viral DNA/RNA reference material, recombinant viral antigens, positive and negative control matrices.
- Development of assay protocol: sample preparation, nucleic acid extraction or antigen capture, assay reaction conditions (primer/probe design, antibody/antigen pairing, blocking conditions, incubation parameters). For instance, a flow-cytometry based titration assay for HSV-1 provides improved linear range over traditional plaque assay.
- Iterative optimization of key parameters: reaction efficiency, background/blank signal, dynamic range, robustness (e.g., matrix effects, interfering substances).
- Performance verification: determination of analytical sensitivity (limit of detection, LOD), analytical specificity (cross-reactivity with other HHV subtypes or human DNA/RNA), precision (intra- and inter-assay CVs), and linearity. In an HHV immunoassay context, development of ELISA versus IFA for HHV-7 seroprevalence established correlation of 96 %.
- Documentation of raw data, graphs (standard curves, dynamic range plots, specificity panels), and out-of-specification investigations.
- Preparation of a draft assay development package: protocol, performance summary report, raw data appendices, reagent list with CoA alignment, and risk/mitigation record.
c) Assay Transfer & Qualification
- Support for analytical verification in client's lab or transfer to partner site: including training, SOP adaptation, and hand-over of key reagents and calibration standards.
- Assistance with assay qualification: verification of performance in the specific intended use matrix (e.g., serum, plasma, tissue homogenate, cerebrospinal fluid) and adaptation of sample handling workflows.
- Supply of a qualification summary report including an executive summary, key performance metrics, deviation log, and recommendations for moving into further development or pre-clinical validation.
- Optional services: assistance with regulatory-style documentation (e.g., design history file, traceability matrix for reagents, deviation/incident log), and standard operating procedure (SOP) writing consistent with ISO 9001/QMS frameworks and diagnostic assay development best practices.
Why Choose CD BioSciences for HHV Assay Development
HHV-Specialised Expertise
Unlike general assay development providers, CD BioSciences focuses exclusively on human herpesviruses (HHVs) and related translational research needs. Our team includes virologists experienced in HHV latency and reactivation models, molecular biologists proficient in HHV-specific nucleic acid assays, and immunologists with expertise in herpesvirus antigen/antibody platforms. This domain-specialisation means we bring immediate understanding of HHV biology, pitfalls (e.g., low-level latent reservoir detection, cross-subtype interference), and best practices for reproducible assay design.
Quality-Focused and Pre-clinical Ready
Our workflows are built around early adoption of QMS-style documentation, reagent traceability, and performance metrics aligned with diagnostic assay development—even though our services are research/pre-clinical stage. The user's interest in regulatory frameworks (e.g., ISO 9001, EN/USP enzyme standards, LAL endotoxin assays) aligns with our own disciplined approach: we supply CoAs for reagents, detailed risk analysis for assay components (e.g., antibodies, viral stocks), and structured reporting packages. This means when you progress further into translational or eventual clinical-evaluation (by others), your assay data has a stronger foundation and audit-ready documentation.
Customisation and Flexibility
We understand that HHV assay needs differ widely by client: some may need ultra-low-level latent HHV detection in companion animal models, others may focus on serologic immunogenicity for vaccine platforms, yet others may need high-throughput screening of antiviral compounds via viral load reduction assays. CD BioSciences offers flexible customised workflows: from simple ELISA/antigen capture assay builds to multiplex host-biomarker panels, high-throughput nucleic acid detection (qPCR, ddPCR), or tailored flow-cytometry based viral quantification systems. For example, a flow cytometry titration assay for HSV-1 demonstrated improved speed and linear range over plaque assay.
End-to-End Support and Clear Deliverables
Our service package is structured with clear deliverables at each phase (design review, optimization report, qualification summary) and transparent cost-structure (as appropriate for research/pre-clinical stage). We maintain a collaborative client interface, with regular milestone meetings, risk-tracker dashboards, and raw data access. Our focus is on enabling you—our client—to move rapidly through assay development and into your downstream workflows (e.g., biomarker screening, antiviral hit confirmation, vaccine immunogenicity read-out) with confidence in assay performance.
Typical Workflow & Timeline
Here is a representative workflow for a typical HHV assay development project (actual timelines and scope will vary depending on complexity and client requirements):
1. Kick-off & Concept Review (Weeks 0-2)
- Virtual meeting to define analyte, sample matrix, performance goals.
- Documentation of project plan, milestone schedule, go/no-go criteria.
- Reagent sourcing list and budget review.
2. Assay Build & Optimization (Weeks 3-10)
- Reagent procurement and qualification.
- Protocol development (e.g., extraction, amplification or capture).
- Iterative optimization rounds (e.g., primer/probe concentration, antibody pairing, blocking conditions, matrix suppression).
- Analytical sensitivity/specificity assessment, generation of standard curves, dynamic range characterization.
3. Pre-qualification & Reporting (Weeks 10-14)
- Precision (repeatability and reproducibility) testing across multiple runs and operators.
- Matrix effect and sample stability testing.
- Cross-reactivity panels (e.g., closely related HHV species, human genomic DNA/RNA interference).
- Preparation of draft assay development report with raw data annex.
Transfer and Qualification Support (Weeks 15-18)
- Provide training to client lab or partner site.
- Assist in SOP finalization, reagent hand-over, and troubleshooting.
- Produce final qualification report summarizing assay performance against defined metrics.
- Optional phase: support for moving assay into companion pre-clinical studies (outside scope of clinical-stage service).
Throughout, we maintain records that align with QMS-style documentation: reagent batch/lot-traceability, deviation logs, risk-mitigation registers, and full data archives. This approach helps support audit readiness and downstream hand-off.
Key Success Factors & Our Quality Assurance
To ensure high-quality deliverables, CD BioSciences emphasises the following success factors:
- Reagent quality and traceability: from viral stocks or antigen preparations to antibodies and nucleic acid standards we use certified materials wherever possible and maintain Certificates of Analysis (CoA) and reagent logs.
- Assay performance transparency: we report LOD, linear range, dynamic range, specificity, precision (CVs), reproducibility and matrix effect data in a clear format.
- Cross-reactivity management: because HHV species share conserved genomic and antigenic features, we build in rigorous cross-reactivity panels (for example PCR consensus primers for herpesvirus families) to mitigate false positives.
- Latency/low-copy detection considerations: for latent HHV reservoirs or low-level viral presence, we address sample processing workflows, enrichment strategies, and inhibitor-removal methods.
- Documentation and hand-off readiness: we provide full protocol sets, SOPs adapted to your lab environment, assay development reports, and offer hand-over support.
- Client alignment and communication: from project initiation to final deliverable, we maintain milestone updates, risk-registries, and decision-gates to keep the project on track and aligned with your objectives.
Use-Cases & Typical Applications
Clients engaging our Assay Development Support for HHV often fall into one of several categories:
- Antiviral discovery screening: e.g., you are developing a novel small-molecule inhibitor targeting a HHV latency protein (such as LANA of KSHV) and you need a quantitative viral DNA or antigen assay to monitor reduction of latent reservoirs or reactivation events.
- Vaccine immunogenicity / candidate evaluation: your team is building a vaccine against HHV (e.g., EBV, KSHV) and you need an antigen-capture assay or immune-response biomarker assay to evaluate candidate performance in pre-clinical animal models.
- Biomarker discovery & verification: you are investigating host-response biomarkers (cytokines, microRNAs, cell surface markers) associated with HHV reactivation or disease progression and require a multiplex immunoassay or custom panel to measure target analytes in specimen panels.
- Diagnostic assay prototyping: you are planning a next-generation HHV diagnostic (nucleic acid or antigen-based) and require an early-stage development partner to build and validate an assay protocol prior to formal translational or clinical evaluation.
In each scenario, CD BioSciences ensures that your assay is developed with HHV-specific scientific rigour, documented for pre-clinical data-generation, and aligned for later transition (though note we focus on research/pre-clinical stage only, not full clinical-diagnostic regulatory submissions).
Why this Matters for Your Programme
By choosing our Assay Development Support service you gain:
- Reduced time-to-data: a dedicated HHV-experienced team accelerates assay build and optimization, avoiding common pitfalls such as cross-reactivity, low-copy viral detection, or assay drift.
- High confidence in results: thanks to transparent performance metrics, reproducibility testing, and documentation, you minimise risk of downstream surprises.
- Regulatory-ready foundation: while not a full clinical regulatory service, the early adoption of quality-oriented documentation and traceability supports your future translational or commercial path.
- Strategic flexibility: you retain full ownership of your assay and data; our model is service-based and supports your internal research/pre-clinical workflows without requiring exclusive long-term commitments.
- Domain-specific niche advantage: because the HHV field is specialised and challenging, having a partner with hands-on experience provides a competitive edge in antiviral, vaccine or diagnostic projects.
FAQs
In the rapidly evolving field of herpesvirus research—whether antivirals, vaccines, biomarkers, or translational diagnostics—assay development is foundational. Partnering with CD BioSciences' Assay Development Support service gives you HHV-specialist expertise, regulatory-aware workflows, and customised deliverables suited for research and pre-clinical stage diagnostics. Our focus on deep documentation, reproducible performance, and strategic flexibility makes us an ideal ally for organisations advancing HHV-centric pipelines.
We look forward to discussing how we can support your next HHV assay development programme and help you accelerate your path from concept to data-generation with confidence and clarity.
References
- Johnson G, et al. Comprehensive PCR-Based Assay for Detection and Species Identification of All Eight Known Human Herpesviruses. J Clin Microbiol. 2000.
- Inoue N, et al. New Immunofluorescence Assays for Detection of Human Herpesvirus 8 (HHV-8). J Clin Microbiol. 2000.
- Nath P, et al. Diagnosis of Herpes Simplex Virus: Laboratory and Point-of-Care Considerations. Front Microbiol. 2021.
- Puglia ALP, et al. Development of an Enzyme-Linked Immunosorbent Assay for HHV-7 Seroprevalence. Virol J. 2020.
- Maini G, Cianci G, Ferraresi M, et al. DNA-Based Technology for Herpesvirus Detection: Review. DNA. 2024;4(4):553-581.
- Okoh GR, Lockhart M, Grimsey J et al. Development of Subfamily-Based Consensus PCR Assays for the Detection of Human and Animal Herpesviruses. Eur J Clin Microbiol Infect Dis. 2023.
- Kennedy MA, et al. TRUSTED: A Targeted Mass Spectrometry Assay for Pan-Herpesvirus Protein Monitoring. Cell Rep. 2022.
- Lu L, Fan M, Li X, et al. Herpesvirus-Associated Diseases: Biomarkers and Advancements in Clinical Research. Virol J. 2025;22:177.