Diagnostics

Microbiome

The Microbiome Group leads the development of DNA and whole‑cell standards for analysis of the Gut, Respiratory, Skin, Oral Cavity and Vaginal microbiomes. Our work supports high‑quality, reproducible microbiome research by providing robust reference materials across diverse microbial communities and promoting harmonisation of microbiome data worldwide.

We also focus on advancing rapid diagnostics for bacterial infections, improving limits of detection, and deepening understanding of how microbes interact with one another and with the human host. Our research covers the microbiome’s role in antimicrobial resistance (AMR), AMR surveillance and resistome analysis, rapid NGS‑based diagnostics, cancer immunotherapies, vaginal infections, and drug-microbiome interactions including microbiotoxicity.

To strengthen AMR efforts, we are developing reference reagents for AMR gene detection. These reagents are intended to establish the accuracy of AMR gene detection tools, define the resistome within samples, and support the harmonisation of sequencing methods and analytical pipelines.

Recent publications:

DNA reference reagents islate biases in microbiome profiling: a global multi-lab study

Microbiotoxicity: an under-recognised player in drug efficacy, toxicity and health outcomes

For more information contact saba.anwar@mhra.gov.uk.

GAMRIF-MHRA Programme

In 2024, the MHRA received a three-year grant from the Global Antimicrobial Resistance Innovation Fund (GAMRIF), a DHSC-led programme that supports the international community in tackling the growing threat of antimicrobial resistance (AMR). The GAMRIF-funded team at the MHRA is developing an in-depth knowledge of new technologies and building an AMR community with various stakeholders and partners, particularly in low- and middle-income countries. Through engagements with GAMRIF delivery partners and project leads, the MHRA can keep pace with scientific advances and identify ways to support research and innovation in the AMR space.

Find out more here, or contact carmen.coxon@mhra.gov.uk.

High Consequence Pathogens

The High Consequence Pathogens group focuses on the development, validation, and standardisation of safe (low containment), high-throughput and accessible (low cost) assays to evaluate diagnostics and medical countermeasures to viruses in the priority families such as Arenaviruses, Coronaviruses, Filoviruses, Bunyaviruses and Poxviruses.

Our activities are aligned with international regulatory expectations and aim to support consistent, high-quality data generation across diagnostics development, therapeutic evaluation, and other medical countermeasure programmes. We are part of the Coalition for Epidemic Preparedness Innovations (CEPI) Centralised Laboratories Network and lead on standardisation programmes for priority pathogens on behalf of the WHO.

Our mission is to promote fit‑for‑purpose, validated, and harmonised assays that enable robust assessment of product performance—spanning diagnostics, therapeutics, and vaccines—in both preclinical and clinical settings

Recent publications:

A system to rapidly develop a bunyavirus pseudotyped virus neutralisation assay for pandemic preparedness.

Standardised quantiative assays for anti-SARS-CoV-2 immune response used in vaccine clinical trials by the CEPI Centralized Laboratory Network: a qualification analysis

For more information contact giada.mattiuzzo@mhra.gov.uk

Genomics

The Genomics group leads the development of novel WHO reference materials to support the harmonisation of performance and measurement of genomic diagnostic tests for oncology and genetic disorders. We also have a strong interest in bioinformatics tools and pipeline for the analysis of genomic data as well as applications of multi-omics in oncology diagnostics.

Our reference materials are prepared from cell lines established from patients, or genetically manipulated cell lines to create mutations of interest. As such, our materials do not harbour recognition sequences or viral constructs, and thus fully mimic patient DNA.

Recent publications

Next-generation methods for more precise measurement of cancer genetic changes

Find more information contact grmteam@mhra.gov.uk.

Serological Standards

The Serological Standards team performs research to develop new globally recognised reference materials that ensure the accuracy, reliability, and comparability of diagnostic tests. We support both antibody-based (serological) and molecular (Nucleic Acid Testing; NAT) assays, enabling laboratories, manufacturers and public health organisations worldwide to calibrate their tests against a common reference standard. This work underpins safe clinical decision-making, blood and transplant safety and effective responses to emerging infectious diseases.

The team particularly works to establish correlates of protection for reference materials to support stakeholders. Through close collaboration with global partners the team plays a key role in harmonising diagnostic measurements, supporting regulatory decision-making and ensuring robust pandemic preparedness.

For more information contact Sarah.kempster@mhra.gov.uk

Recent publications:

Protective titre of the WHO International Standard for anti-Chikungunya virus antibodies in a mouse model

Convalescent human plasma candidate reference materials protect against Crimean-Congo haemorrhagic fever virus (CCHFV) challenge in an A129 mouse model

Centre for Infectious Disease Reagents (CIDR)

The CIDR curates a portfolio of research reagents for infectious diseases. It was established in 1989 as the Centre for AIDS Reagents (CFAR) but was re-named recently to reflects its expanding reagent portfolio covering a broader range of infectious diseases, including SARS-CoV-2, Hepatitis B, Hepatitis C, malaria and tuberculosis.

Find out more here, or contact cidr@mhra.gov.uk

CJD Research & Resource Centre

The CJD Research & Resource Centre curates extremely valuable materials that may be used to establish the suitability of assays to detect “infectious” variant Creutzfeldt Jacob Disease (vCJD) in blood or other biological materials. We are also investigating how to standardise measurement in novel highly sensitive methods for the detection of other neurodegenerative diseases such as Parkinson’s and Alzheimer’s.

Find out more here or contact jillian.cooper@mhra.gov.uk.