Rapid testing for sexually transmitted infections on the horizon
The funding covers a work including the first test of the technology on clinical samples in a real-world setting and readiness for clinical trials.
Linear is developing a low-cost, accurate, near-patient diagnostic platform, that aims to diagnose infection from a single sample faster than any commercially available alternative.
Birmingham spin-out Linear Diagnostics has been awarded £1m funding to finalise the development of a rapid test for sexually transmitted infections (STIs), in partnership with the NIHR HealthTech Research Centre (HRC) in Diagnostic and Technology Evaluation and the North East Innovation Lab, part of Newcastle Hospitals.
Linear is developing a low-cost, accurate, near-patient diagnostic platform, that aims to diagnose infection from a single sample faster than any commercially available alternative.
The funding from the National Institute for Health and Care Research (NIHR) Invention for Innovation programme covers a three-year package of work, which will culminate in the first test of the technology on clinical samples in a real-world setting, and readiness for clinical trials.
The most difficult criteria to achieve in diagnostic testing is combining rapidity with accuracy. While rapid lateral flow meets the ideal timeframe of 20 minutes to diagnosis, it struggles to meet market requirements for high sensitivity and specificity. And while Nucleic Acid Amplification Tests deliver high accuracy, samples are sent to laboratories for analysis, meaning the waiting time for results may be days. We are developing a near patient device that will overcome this conundrum.
Linear’s Exponential Amplification (EXPAR) technology detects bacterial DNA using an extremely fast method for amplifying the signal, which was developed and tested at the University during the COVID-19 pandemic, with results published in Proceedings of the National Academy of Sciences. The company has now shown that it can detect bacterial STIs, urinary tract infections, and viral infections including SARS-CoV-2 in as little as 5 minutes.
In recent years the company has focussed on STIs, specifically Neisseria gonorrhoeae and Chlamydia trachomatis as the emergence of multi-drug-resistant strain of the former has become a global concern.
It is here that rapid testing is essential to stop the chain of transmission, so patients can be diagnosed and start treatment within one clinic visit. While current tests may be easy to use with minimal training, existing technologies have been unable to meet the target of 20 minutes from sample to results.
The new funding will enable Linear to finalise the design of a cartridge and reader design platform and validate the platform.
Dr Jean-Louis Duprey, Head of Research and Development at Linear Diagnostics, said: “The most difficult criteria to achieve in diagnostic testing is combining rapidity with accuracy. While rapid lateral flow meets the ideal timeframe of 20 minutes to diagnosis, it struggles to meet market requirements for high sensitivity and specificity. And while Nucleic Acid Amplification Tests deliver high accuracy, samples are sent to laboratories for analysis, meaning the waiting time for results may be days. We are developing a near patient device that will overcome this conundrum.”
The HRC, hosted by Newcastle upon Tyne Hospitals NHS Foundation Trust in partnership with Newcastle University, will help to evaluate the technology.
Dr Jana Suklan, Senior Methodologist at the HRC, said: “The NIHR HRC in Diagnostic and Technology Evaluation is delighted to be collaborating with the North East Innovation Lab to support Linear Diagnostics with their exciting technology. Through reviewing clinical guidelines and speaking with healthcare professionals as well as patients and the public we will pinpoint how the platform can be developed and used so it can improve patient care.”
“Our research involves analysing unmet needs, examining current practice and identifying the most promising point in the patient pathway for implementing the technology. We will also assess the diagnostic accuracy of the test by statistically analysing data collected by the innovation lab and determine whether adopting the technology will provide value for money for the NHS through health economic modelling. Our public contributors will guide the research and ensure it meets the needs of patients, public and carers.”
John Tyson, Head of the North East Innovation Lab, part of Newcastle Hospitals, said: “We’re delighted to have the opportunity to continue our collaborative work with our partner innovators to support the development and evaluation of this new exciting diagnostic test. By providing access to an extensive range of clinical samples and NHS lab performance testing, we can generate the necessary evidence to move new innovative technologies to the next stage of their development or to launch for mainstream use.”
Notes for editors
Notes for editors
For media information contact Ruth Ashton, University of Birmingham Enterprise, email: r.c.ashton@bham.ac.uk
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About Linear Diagnostics
Linear Diagnostics exploits a novel platform technology that can be used for assays in a wide range of sectors including food, agriculture, defence and security, veterinary, and medicine. The technology uses linear dichroism, which enables rapid detection of multiple targets using a disposable cartridge run on a small low-cost instrument that has the potential to deliver rapid, accurate and cost-effective diagnostic testing without the need for laboratory facilities.
The company is now developing a low-cost, near patient, diagnostic that can identify Chlamydia trachomatis and Neisseria gonorrhoea from a single sample, within a 20-minute timescale, making it faster than any current alternative.
The National Institute for Health and Care Research (NIHR) HealthTech Research Centre (HRC) in Diagnostic and Technology Evaluation is part of the NIHR and hosted by Newcastle Hospitals in partnership with Newcastle University.
About the National Institute for Health and Care Research (NIHR)
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
- funding high quality, timely research that benefits the NHS, public health and social care
- investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services
- partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research
- attracting, training and supporting the best researchers to tackle complex health and social care challenges
- collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system
- funding applied global health research and training to meet the needs of the poorest people in low and middle income countries
NIHR is funded by the Department of Health and Social Care.
Our work in low and middle income countries is principally funded through UK international development funding from the UK government.
About Newcastle Hospitals
Newcastle Hospitals provides care to patients and their families, across communities in the North East of England and beyond, with 6,500 patient contacts every day. We are one of the largest NHS Trusts in the UK, offering a wide range of specialist services, in the community and across our hospital sites which include the Royal Victoria Infirmary, the Freeman Hospital, Great North Children’s Hospital, Campus for Ageing and Vitality, Newcastle Dental Hospital, Newcastle Fertility Centre and the Northern Centre for Cancer Care. We have a long history of providing high quality care, clinical excellence, and innovation in medical research regionally, nationally and internationally.
About Newcastle University
Newcastle University, UK, is a thriving international community of more than 28,000 students from over 130 countries worldwide. As a member of the Russell Group of research-intensive universities in the UK, Newcastle has a world-class reputation for research excellence in the fields of medicine, science and engineering, social sciences and the humanities. Its academics are sharply focused on responding to the major challenges facing society today. Research and teaching are world-leading in areas as diverse as health, culture, technology and the environment.
Newcastle is committed to providing students with excellent, research-led teaching delivered by dedicated and passionate teachers. Newcastle University is ranked 110th in the QS World Ranking 2024 and joint 139th in the Times Higher Education World University Ranking 2023. Newcastle University is ranked fourth in the UK and joint 24th in the world for sustainable development in the Times Higher Education Impact Rankings 2023.
Newcastle upon Tyne NHS Foundation Trust and Newcastle University are both part of Newcastle Health Research Partnership. NHRP is one of eight Academic Health Science Centres (AHSCs) across the UK, bringing together partners to translate cutting-edge research into excellent patient care and support world-class training and education with a focus on public partnerships.