STI A revolutionary STI test developed by UK-based Linear Diagnostics, a University of Birmingham spin-out company, delivers lab-accurate results in five minutes
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.
The research is detailed in the Proceedings of the National Academy of Sciences.
Linear unveils ultra-fast, low-cost STI test from a single sample
The STI test is low-cost, accurate, and aims to diagnose infection from a single sample faster than any commercially available alternative.
The project received funding from the National Institute for Health and Care Research (NIHR) Invention for Innovation program and covers a three-year package of work, which includes a first test of the technology on clinical samples in a real-world setting and readiness for clinical trials.
Linear Exponential Amplification (EXPAR) technology detects bacterial DNA using a speedy method for amplifying the signal, which was developed and tested at the University during the COVID-19 pandemic. The test detects bacterial STIs, urinary tract infections, and viral infections, including SARS-CoV-2, in under five minutes.
Linear targets STIs as drug-resistant gonorrhoea sparks global alarm
The company has specifically focused on Neisseria gonorrhoeae and Chlamydia trachomatis following the emergence of multidrug-resistant strains of the former, which have become a global concern.
Rapid STI testing is crucial in breaking the chain of transmission, enabling patients to be diagnosed and receive treatment promptly. However, 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 STI 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. While Nucleic Acid Amplification Tests deliver high accuracy, samples are sent to laboratories for analysis, resulting in a waiting time of several days for the results. We are developing a near-patient device that will overcome this conundrum.”
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, the 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 STI 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 launch to mainstream use.”
