Shaping global health policy through the evaluation & validation of game-changing diagnostics

iiCON and Liverpool School of Tropical Medicine (LSTM) are playing a key role in supporting the global effort to evaluate high-quality diagnostic tests and shape international health policy – benefiting communities across the world.

The consortium’s specialist diagnostics capability is led by lead partner LSTM. As a UK evaluation site for the global Foundation for Innovative Diagnostics (FIND) it is making a key contribution to the development of game-changing diagnostics that are saving and improving lives – particularly in the battle against COVID-19.

Working through the COVID-19 pandemic, this hub of diagnostics research expertise has been able to leverage LSTM’s world-leading diagnostics expertise and facilities, including the largest complement of Containment Level Three laboratories in the North West, able to handle and process hazardous pathogens, including the live SARS-COV-2 virus

The platform is currently working with the main SARS-COV-2 variants of concern including the Alpha, Beta, Gamma and Omicron variants. It plans to add more strains to its testing remit if they emerge – supporting industry efforts to develop new diagnostics as COVID-19 evolves.

Following confirmation of FIND evaluation site status in 2020, advanced analytical and clinical testing has enabled the evaluation of over 50 rapid lateral flow tests (LFT) for antigen and antibody detection.

This sophisticated evaluation of diagnostics is helping to shape and influence global policy. The results of these evaluations are published by FIND, with the resulting data used by organisations including the World Health Organisation (WHO) to inform procurement decisions.

Data generated by LSTM has also enabled regulatory approval through CE marking, Medicines and Healthcare products Regulatory Agency (MHRA) and Food and Drug Administration (FDA) helping to fast-track effective, safe diagnostics to symptomatic and asymptomatic patients and communities and rapidly identify and halt the spread of the virus.

Dr Ana Cubas Atienzar, Post-Doctoral Research Associate at LSTM, said: “We are incredibly proud to be playing such a key role in the global COVID-19 effort. As the UK’s only FIND evaluation site, we have evaluated over 50 LFT for both antigen and antibody detection- utilising LSTM’s world-leading research expertise and facilities to support the evaluation of innovative diagnostics that have helped communities across the globe”

“The pandemic has highlighted the importance of rapid, effective diagnostics to monitor and control the spread of the viruses and we’re delighted to be able to support this industry innovation. As iiCON lead partner, we are working on a number of exciting projects to validate innovative diagnostics, working with industry to support the journey to market, and bring new effective solutions to patients and consumers as quickly, safely, and affordably as possible.”