At CD BioSciences, we specialize in supporting the research and pre-clinical development of antiviral drugs, vaccines, and diagnostic tools targeting Human Herpesviruses (HHVs). Our Biomarker Discovery & Validation Solutions enable clients to identify, verify, and translate molecular signatures that define infection status, latency, immune response, and therapeutic efficacy across alpha-, beta-, and gamma-herpesvirus species.
By integrating multi-omics analytics, bioinformatics pipelines, and pre-clinical assay platforms, we help biopharmaceutical companies and research institutions transform raw data into actionable biological insights—supporting candidate selection, mechanism elucidation, and companion diagnostic development.
The Role of Biomarkers in HHV Research
Biomarkers serve as critical tools in understanding the pathogenesis, latency, and reactivation of HHVs, as well as in monitoring disease progression and treatment outcomes. For viruses such as HSV-1/2, VZV, CMV, EBV, and KSHV, distinct classes of biomarkers—including viral nucleic acids, viral and host proteins, immune signatures, and metabolic shifts—provide valuable indicators of viral activity and host response.
At CD BioSciences, we recognize that biomarker discovery for HHVs presents unique challenges due to their lifelong persistence, cell-type specificity, and latent–lytic switch mechanisms. Our platform addresses these complexities through tailored strategies for each virus subtype and experimental context.
Our Comprehensive Biomarker Discovery Workflow
We employ a multi-tiered and data-driven biomarker discovery framework built upon translational virology expertise:
Step 1 – Target Definition and Study Design
Our experts collaborate with clients to define study goals—whether for identifying diagnostic markers, immunological correlates of protection, or therapeutic response indicators. We help select appropriate biological matrices (e.g., serum, PBMCs, cerebrospinal fluid, tumor biopsies) and establish standardized collection and preservation protocols to ensure sample integrity.
Step 2 – Omics-Based Discovery
We apply multi-omics profiling to capture a complete molecular landscape:
- Transcriptomics: RNA-Seq for viral and host gene expression profiling.
- Proteomics: Quantitative LC-MS/MS to identify viral or host proteins linked to infection dynamics.
- Metabolomics & Lipidomics: LC/GC-MS analyses to reveal metabolic signatures associated with latency or reactivation.
- Epigenomics: Chromatin and methylation mapping to understand latent genome regulation.
Step 3 – Bioinformatics Integration & Candidate Prioritization
Advanced computational analysis integrates multi-omics datasets to uncover biomarker candidates. Our pipelines perform:
- Network-based modeling of host–virus interactions.
- Machine learning–assisted feature selection.
- Pathway enrichment analysis to identify mechanistic links.
Candidates are then prioritized based on biological relevance, clinical translatability, and detection feasibility.
Step 4 – Analytical and Biological Validation
We perform multi-level validation combining quantitative molecular assays and biological model systems:
- qPCR / ddPCR validation for nucleic acid biomarkers.
- ELISA, Luminex, and Western blot for protein biomarkers.
- Flow cytometry for immune cell profiling.
- Functional assays in cell-based or animal infection models to confirm mechanistic association.
All validation processes adhere to MIQE, CLSI, and FDA bioanalytical method validation guidelines to ensure reproducibility and robustness.
Step 5 – Translational & Pre-clinical Application Support
Validated biomarkers are integrated into translational research contexts, including:
- Pre-clinical efficacy or toxicity studies.
- Pharmacodynamic (PD) and mechanism-of-action (MoA) readouts.
- Early companion diagnostic assay development.
Key Areas of Expertise
Our HHV-focused biomarker discovery programs span multiple virus groups and disease settings:
- HSV-1/2: Biomarkers for neurotropism, latency in trigeminal ganglia, and antiviral response.
- VZV: Correlates of vaccine-induced immunity and reactivation triggers.
- CMV: Predictive markers for viral load control and immune restoration in transplant models.
- EBV: Serum and cellular biomarkers for lymphoproliferative disorders and nasopharyngeal carcinoma.
- KSHV (HHV-8): Latency-associated biomarkers, including LANA, vIL-6, and angiogenic factors in Kaposi's sarcoma and PEL models.
Each program leverages virus-specific infection models and validated reference standards to ensure high translational relevance.
Analytical Platforms and Technologies
CD BioSciences integrates a broad range of state-of-the-art analytical platforms, enabling both discovery and validation phases:
- High-resolution LC-MS/MS and Orbitrap systems for proteomic biomarker identification.
- Next-generation sequencing (NGS) for viral genomics and host transcriptome analysis.
- Multiplex cytokine and chemokine profiling platforms for immunological biomarker studies.
- Automated ELISA and immunoassay systems for quantitative validation.
- Digital PCR and Nanostring for ultra-sensitive nucleic acid detection.
- Advanced data visualization and AI-based clustering for biomarker pattern recognition.
All analytical workflows operate under GLP-like research standards, ensuring reproducibility, traceability, and scientific integrity.
Advantages of Partnering with CD BioSciences
Choosing CD BioSciences means gaining a specialized partner focused exclusively on HHV-related research and pre-clinical development. Our competitive advantages include:
- HHV Specialization: Decades of cumulative expertise in herpesvirus biology, latency models, and host–pathogen interaction mechanisms.
- Integrated Multi-Omics Approach: Comprehensive discovery spanning genomics to metabolomics, ensuring unbiased candidate identification.
- Pre-clinical Relevance: Biomarker validation using authentic infection and latency models rather than generic cell lines.
- Regulatory-Ready Documentation: Data packages aligned with international assay validation guidelines (CLSI, IFCC, FDA).
- Collaborative Flexibility: Fully customizable project design—from exploratory biomarker screening to confirmatory validation studies.
Our commitment is to deliver scientifically rigorous, reproducible, and actionable biomarker data that accelerate your HHV-focused R&D pipeline.
Typical Deliverables
At project completion, clients receive a comprehensive Biomarker Discovery & Validation Report including:
- Detailed study design and experimental protocols.
- Candidate biomarker lists with statistical significance metrics.
- Functional and pathway annotations.
- Validation assay results with raw and processed data.
- Custom assay SOPs for client implementation.
- Recommendations for further translational or pre-clinical evaluation.
These deliverables ensure smooth integration into ongoing antiviral drug discovery, vaccine evaluation, or diagnostic development programs.
Applications Across the HHV R&D Spectrum
Our biomarker discovery and validation solutions directly support multiple R&D stages:
- Drug Discovery: Identification of PD markers for efficacy assessment.
- Vaccine Development: Discovery of immune correlates of protection and durability markers.
- Diagnostics Development: Definition of molecular signatures for early infection detection.
- Gene & Oncolytic Virus Therapy: Biomarker tracking of vector performance, immune modulation, and tumor response.
By bridging discovery research and pre-clinical validation, CD BioSciences helps transform scientific discoveries into translational outcomes.
Quality, Compliance, and Data Integrity
Every study follows our internal Quality Management System (QMS) based on ISO 9001 principles. All analytical data undergo multi-level review to ensure scientific accuracy and regulatory alignment. We maintain strict data confidentiality and provide clients with full ownership of project-generated datasets.
Partner With CD BioSciences
At CD BioSciences, we believe that robust and validated biomarkers are the foundation of effective HHV-targeted innovations. Whether you are designing a diagnostic assay, screening antivirals, or exploring vaccine responses, our integrated biomarker discovery and validation solutions are designed to accelerate your program from mechanistic insight to pre-clinical validation.
Contact us to discuss your HHV-focused biomarker needs and discover how we can help advance your discovery programs toward translational success.
References
- Hislop AD et al., Nat Rev Microbiol. 2023;21(1):25–42. "Host–virus interactions in herpesvirus persistence and latency."
- Paludan SR et al., Nat Rev Immunol. 2022;22(3):144–159. "Immunological correlates of herpesvirus infection and reactivation."
- Grundhoff A, Ganem D. Nat Rev Microbiol. 2021;19(11):698–714. "Mechanisms of latency control in gammaherpesviruses."
- Depledge DP et al., Front Microbiol. 2022;13:851421. "Omics-based approaches for herpesvirus biomarker discovery."
- CLSI EP17-A3. "Protocols for Determination of Limits of Detection and Limits of Quantitation." Clinical and Laboratory Standards Institute, 2021.