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PeploBio Launches Proprietary assay for Microclot Detection
Services
MicroCLOT
Uncover the Hidden Biology of Chronic Disease
MicroCLOT Detection in Clinical Trials
At PeploBio, we work with pharmaceutical and biotech sponsors to explore the emerging role of microclots in chronic disease. By Combining advance flow cytometry, robust biomarkers validation, and clinical insight, we accelerate research into hard-to-treat, immune-mediated conditions such as Long COVID, ME/CFS, Lyme disease and other forms of Chronic Inflammation.
Introducing the MicroCLOT Assay
The MicroCLOT assay is a proprietary platform for the detection and quantification of fibrinogen amyloid microclots in fresh and frozen bloods samples - an increasingly recognised pathological hallmark in post-viral syndromes and persistent inflammatory conditions.
Researchers and clinicians studying Long COVID, ME/CFS, or pst-treatment Lyme disease syndrome (PTLDS) have identified microclots as key contributors to ongoing symptoms like fatigue, brain fog, pain, and autonomic dysfunction. Our assay translates this research into a practical tool for clinical application.
Why Microclots Matter in Chronic Disease
Microclots are amyloid-like fibrin(ogen) aggregates that resist natural breakdown processes, contributing to vascular obstruction, endothelial damage, and immune dysregulation. Elevated levels of inflammatory cytokines such as IL-6, TNFα, and MCP-1 have been strongly associated with microclot formation in patients suffering from:
- Long COVID (PASC) - ME/CFS - Chronic Lyme disease - Autoimmune flare-ups - Cancer immunotherapy-related toxicities
The MicroCLOT Assay enables drug developers to quantify the previously hidden burden with clinical precision.
Assay Capabilites
Using high-throughput flow cytometry, the MicroCLOT Assay Offers:
- Quantitative microclots profilling: count, size, and area distribution - Differentiation between disease and healthy plasma samples - Use with fresh or frozen banked samples - Deployment in both retrospective and prospective clinical trials
Supporting Clinical Trials in Chronic Inflammation and Post-infectious Syndromes
PeploBio has delivered clinical trial support across the UK, EU, USA and Australia, with a focus on:
- Immuno-oncology - Post-viral Syndromes (e.g., Long COVID, Lyme, ME/CFS) - Inflammatory and infectious disease-based diagnostics
We offer CRO-aligned services to integrate microclot detection into:
- Measurement of changes pre- and post-treatment - Patient Stratification - Mechanism-of-action (MOA) / pharmacodynamic (PD) studies - Drug repurposing in chronic inflammatory condition
Designed for Clinical Research
We support both prospective and retrospective study models:
Prospective cohorts - Sample collection, testing, and analysis from new or ongoing clinical trials
Retrospective analysis - Use archived plasma from past studies, registries, or biobanks Our scientific team works with you from exploratory assays to protocol design through regulatory support, assay deployment, and clinical data analysis.
Services
Clinical Trials and Biospecimen Sourcing
At PeploBio, we are a leader in clinical trial development and biospecimen sourcing services
Immunoassay
We integrate immunoassay development into our unique suite of services. Immunoassays are critical in clinical diagnostics, allowing you to characterise the quality of your product and fuel clinical decision-making. We offer an array of platforms and capabilities, including BD FACSLyric, Molecular Devices SpectraMax ID5, ELISA, peptide and antibody screening, cellular phenotyping, receptor occupancy, and TBNK.
As part of our immune-monitoring effort, including our ELISA and flow cytometry services, PeploBio provides assays to pharmaceutical companies to support exploratory, phase 1, and phase 2 clinical trials. Additionally, we offer assay validation testing using our regulatory expertise to facilitate the development of companion diagnostics.
Running a clinical trial and bringing your product to market is no easy feat. At PeploBio, we believe in an integrated approach to drug and device development, which is why we offer clinical trial project management services to oversee your program from start to finish.
We provide extensive experience within the cutting-edge realm of genomics. Likewise, PeploBio has several offerings to help you successfully utilize genomic data, including qPCR sequencing, Sanger sequencing, CRISPR, gene silencing, targeted gene expression analysis, and gene sequencing.
High-quality biospecimen procurement is an essential component to progressing your device's program. We have extensive access to biospecimens through a diverse network of collection sites, providing a wide array of biospecimens for your company's individual needs. In addition, PeploBio delivers a host of biospecimen sourcing services in line with quality and bioethical standards.
Secure global market success through PeploBio's regulatory expertise.
Clinical Performance Evaluation
As part of our testing services, we offer performance evaluations including analytical, clinical and usability studies, to align with your specific market objectives.
PeploBio advises on the In Vitro Diagnostic Regulation (IVDR), an essential requirement for any company wishing to market in vitro diagnostic medical devices within the European Union (EU). The IVDR outlines standards for establishing a medical device's quality, safety, and integrity for diagnostics in vitro. IVDR is also accepted in markets like Asia and Africa, broadening your device's potential impact.
Although the United States is a major market, it is one of the most challenging regions to secure approval. We provide consultant services for interacting with the Food and Drug Administration (FDA) and securing FDA approval. PeploBio can provide expertise in developing robust regulatory strategies to achieve success in the US market.
The UKCA marking is critical for those seeking to manufacture certain medical devices in Great Britain. Our services assess your product to ensure conformity with UKCA requirements, allowing you to display the UKCA marking to communicate compliance.
To market COVID-19 test devices in the UK, you must obtain Coronavirus Test Device Approval (CTDA) for your product. PeploBio is an expert in preparing CTDA submissions, maximizing your company's chance of regulatory approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) to market in the UK.
We help you to establish your medical device's Quality Management System (QMS), supporting your accreditation journey. By creating a suite of policies, procedures, and processes within your QMS, you can ensure the safety and efficacy of your product.
Your ultimate partner for comprehensive diagnostic solutions and unmatched expertise
Partner Hub
PeploBio provides diagnostic testing solutions in the fields of oncology, infectious disease, serology, and more. By joining our partnership, you can access various services providing support in digital marketing, kits, account management, and more. Our partner program offers tiered subscription options, ranging from basic to comprehensive packages. By providing a spectrum of services, PeploBio offers customized solutions for everyone suited to your individual needs and goals.
Diagnostic Tests A-Z
Our state-of-the-art diagnostic testing laboratory offers dozens of testing services, securing PeploBio as your one-stop shop for all things diagnostics. In addition to the wide array of tests, our team provides decades of experience in the field of molecular biology, providing the expertise you need for diagnostic testing success.
About PeploBio
Explore Our Competitive Edge
PeploBio is a specialised CRO supporting pharmaceutical and biotechnology companies in clinical trial through advanced testing and immune monitoring services. Operating across two strategically located sites in the UK and US, we combine deep scientific expertise with operation excellence to accelerate drug development.
Our proprietary MicroCLOT assay, designed for the detection and quantification of fibri(nogen) amyloid microclots, is transforming research in Long Covid, ME/CFS, and chronic inflammatory disease. Combined with a full suite of flow cytometry, assay development, validation and companion diagnostic (CDx) services, we help sponsors generate robust biomarker data and meet regulatory expectations.
We are ICO registered, meaning we prioritize data protection and meet the requirements for GDPR compliance.
As a BIVDA member, we have access to cutting-edge regulatory insights, helping to inform robust regulatory strategies and fostering connections across the industry.
Life Sciences Review recognized our lab's excellence and regulatory adherence as the Top Clinical Laboratory Services Company in the UK in 2022.
