Birmingham spin-out Linear Diagnostics has secured £1 million in funding from the National Institute for Health and Care Research (NIHR) Invention for Innovation programme to advance development of a rapid diagnostic test for sexually transmitted infections that delivers results in as little as five minutes.
The three-year project, conducted in partnership with the NIHR HealthTech Research Centre (HRC) in Diagnostic and Technology Evaluation and the North East Innovation Lab at Newcastle Hospitals, will culminate in clinical sample testing and preparation for clinical trials.
Addressing Critical Diagnostic Gap
Linear's Exponential Amplification (EXPAR) technology detects bacterial DNA using an extremely fast signal amplification method originally developed and tested at the University of Birmingham during the COVID-19 pandemic. The company has demonstrated the platform's ability to detect bacterial STIs, urinary tract infections, and viral infections including SARS-CoV-2 in as little as five minutes.
The technology specifically targets Neisseria gonorrhoeae and Chlamydia trachomatis, two bacterial STIs that pose increasing challenges due to antibiotic resistance. The emergence of multi-drug-resistant strains of gonorrhoeae has become a global concern, making rapid testing essential to prevent transmission chains.
"The most difficult criteria to achieve in diagnostic testing is combining rapidity with accuracy," said Dr. Jean-Louis Duprey, Head of Research and Development at Linear Diagnostics. "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."
Overcoming Current Testing Limitations
Existing STI testing technologies face significant limitations that prevent same-day diagnosis and treatment. Current rapid tests may be easy to use with minimal training, but have been unable to meet the target of 20 minutes from sample to results while maintaining accuracy standards.
The Linear platform aims to bridge this gap by developing a near-patient device that combines the speed advantages of lateral flow tests with the accuracy of laboratory-based nucleic acid amplification tests. This approach would enable patients to be diagnosed and start treatment within a single clinic visit, crucial for preventing ongoing transmission.
Collaborative Development Approach
The HRC, hosted by Newcastle upon Tyne Hospitals NHS Foundation Trust in partnership with Newcastle University, will evaluate the technology through comprehensive assessment methods. Dr. Jana Suklan, Senior Methodologist at the HRC, explained their role: "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."
The research will involve analyzing unmet needs, examining current practice, and identifying optimal implementation points in the patient pathway. The team will assess diagnostic accuracy through statistical analysis of data collected by the innovation lab and determine value for money for the NHS through health economic modeling.
John Tyson, Head of the North East Innovation Lab, emphasized the collaborative nature of the project: "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 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."
Technology Development Timeline
The funding will enable Linear to finalize the design of both cartridge and reader components of their diagnostic platform and validate the complete system. The three-year project timeline is structured to progress from platform optimization through clinical sample validation, positioning the technology for subsequent clinical trials and potential market entry.
