Recent advances and implications for immunology and diagnostics
Why biomarker discovery matters for vaccine development
How Bioveritas is Helping to Drive Biomarker-Driven Vaccine Development
The development of modern vaccines and diagnostics hinges on the accurate and rapid identification of **biomarkers**—biological signatures that predict efficacy, safety, and durability. Here’s how a company like **Bioveritas** can provide specialized support to accelerate this critical, data-intensive process.
Bioveritas’s contributions span the full chain from biomarker discovery $\rightarrow$ assay development $\rightarrow$ diagnostics/monitoring $\rightarrow$ vaccine programme support.
Bioveritas can design and validate high-quality immunological assays (e.g., multiplex cytokine panels, gene expression assays, immune repertoire sequencing) that detect and quantify candidate biomarkers. This ensures robust, reproducible biomarker measurement which is foundational for vaccine R&D.
By leveraging their R&D capabilities, Bioveritas could collaborate with vaccine developers to identify biomarker signatures of immune response (humoral, cellular), safety/reactogenicity, and durability. For example, analyzing samples from vaccination trials using multi-omics or immune profiling to identify early predictors of efficacy.
Once biomarkers are validated, Bioveritas can provide diagnostic or monitoring services (in vitro diagnostics, companion assays) that help stratify populations, guide booster timing, assess vaccine take in the field, or monitor immune durability over time.
Being located the UK, Bioveritas is well-positioned to support biomarker/vaccine efforts that are region-specific: accounting for local genetic/immune variation, endemic pathogen exposures, and logistical constraints. This helps ensure biomarker-driven vaccine strategies are globally relevant.
Bioveritas can ensure that biomarker assays and validation processes meet regulatory or good-lab practices, supporting translation of biomarkers into clinical/diagnostic use. This is key to ensuring biomarkers become actionable in vaccine development and diagnostics.
By combining assay data with computational analytics (possibly AI/ML pipelines), Bioveritas can help derive meaningful biomarker patterns from complex data sets, enabling vaccine developers to make data-driven decisions (e.g., which candidates to advance, which adjuvants to use, how to monitor responses).
In the UK, multi-site studies—including NHS-led clinical trials, academic research consortia, and biotech collaborations—are the backbone of modern biomedical innovation. However, these studies often generate fragmented datasets across hospitals, laboratories, and research hubs.
Integrating such data effectively is essential to:
When done properly, data integration transforms multi-site collaboration into a unified research ecosystem.
Bioveritas plays a strategic role in helping UK researchers, diagnostics companies, and biotech firms achieve seamless, compliant, and intelligent data integration.
Bioveritas designs and validates assay workflows to ensure consistency of experimental data across multiple laboratories or NHS sites. This eliminates **cross-site variability**—a common barrier in biomarker and diagnostic studies.
Through advanced data engineering and informatics support, Bioveritas builds integration pipelines that unify clinical, laboratory, and imaging data into a single, interoperable platform. This includes:
Bioveritas ensures that all integrated data meet **MHRA, UK GDPR, and ISO 27001** standards for data protection and quality management, providing structured documentation for audits, ethics submissions, and regulatory inspections.
Using machine learning and advanced analytics, Bioveritas helps extract meaningful insights from integrated data—identifying biomarker patterns, treatment responses, and patient stratification opportunities.
Bioveritas actively partners with universities, NHS research centres, and biotech start-ups. Its infrastructure is designed to plug into UK-wide research networks, promoting secure data sharing and accelerating clinical translation.
By adopting these best practices and leveraging Bioveritas’s expertise, multi-site UK studies can:
Achieving High Sensitivity & Throughput with Bioveritas
Next-generation diagnostics (NGD) refers to advanced diagnostic platforms and workflows that go beyond traditional methods (culture, simple PCR, immunoassays) in two key dimensions:
Sensitivity
The ability to detect very low levels of analyte (pathogen DNA/RNA, biomarker protein, mutant allele, cell‐free DNA, etc.). For example, some NGD methods detect 1-10 copies of target or very low variant allele frequencies.
Throughput
The ability to process many samples (and/or many analytes per sample) in parallel, quickly, and cost-effectively. This involves high sample volumes, multiplexing, and automation.
Together, high sensitivity + high throughput enable diagnostics to be more robust, scalable, and efficient.
Low analyte levels require careful processing (extraction, enrichment) as background nucleic acid can mask detection, especially in metagenomic sequencing.
Maintaining consistency is difficult when multiplexing many targets or processing very high volumes of samples.
High throughput results in large data volumes, complex analytics, and an essential need for robust bioinformatics pipelines.
Sensitive diagnostics require rigorous validation of limits of detection, specificity/sensitivity, and robustness across real-world conditions.
Multiplexing or deep sequencing can sometimes reduce per-target sensitivity or increase the risk of false positives.
Bioveritas supports clients (diagnostic developers, clinical labs, biotech firms) in overcoming these challenges to enable next-generation diagnostics that successfully combine high sensitivity and high throughput.
Design and optimise assays to reach low limits-of-detection (LOD) and high specificity, focusing on sample prep to increase target recovery and reduce noise. They validate assays under high throughput workflows.
Implement and integrate automation, robotics, and design multiplexed assays and pooling strategies to amplify throughput while retaining sensitivity. This reduces turnaround time, crucial for urgent diagnostics.
Provide bioinformatics and data management services for handling large data volumes, implementing QC pipelines, interpreting results, and building reporting frameworks that ensure results are clinically actionable.
Ensure assays meet regulatory standards (e.g., CE-IVD, ISO 13485) and provide documentation and validation reports necessary for large-scale diagnostic deployment and lot-to-lot consistency.
Help diagnostic developers scale from pilot to large rollout (tens to thousands of samples/day), supporting customisation for various use-cases and integration into lab informatics systems.
By leveraging Bioveritas’s capabilities, organizations can realise diagnostics that: