Rapid STI Test Secures £1M Funding, promising results in Minutes

Linear Diagnostics’ new platform aims to deliver fast, accurate STI diagnoses at the point of care.

A Birmingham spin-out,Linear Diagnostics,has received £1 million in funding to finalize a rapid test for sexually transmitted infections (STIs). This advancement could dramatically reduce diagnosis times and improve patient care, addressing a critical need in combating the spread of STIs WHO, 2024.

Funding Boosts Progress

Linear Diagnostics is creating an affordable and precise diagnostic platform intended for near-patient use. The goal is to diagnose infections from a single sample faster than any existing commercial method.The company’s technology could potentially deliver results in as little as 5 minutes.

The funding, provided by the National Institute for Health and Care Research (NIHR) Invention for Innovation program, will support a three-year project. This initiative will culminate in real-world testing of the technology on clinical samples, paving the way for clinical trials.

EXPAR Technology: A Game Changer

Linear’s Exponential Amplification (EXPAR) technology identifies bacterial DNA using a rapid signal amplification method. Originally developed and tested during the COVID-19 pandemic at the University, the technology can detect bacterial STIs, urinary tract infections, and viral infections, including SARS-CoV-2, in approximately 5 minutes.

The company has recently concentrated on STIs, particularly Neisseria gonorrhoeae and Chlamydia trachomatis, due to the increasing global concern over multi-drug-resistant strains.

The need for Speed

Rapid testing is vital to interrupt the transmission chain, enabling patients to receive a diagnosis and begin treatment during a single clinic visit. Current tests often fall short of the desired 20-minute turnaround time from sample to results, even though they may be user-amiable and require minimal training.

The new funding will allow Linear to finalize the design of a cartridge and reader platform and validate it’s effectiveness.

“The most challenging criteria to achieve in diagnostic testing is combining rapidity with accuracy,” said Dr. Jean-Louis Duprey, Head of Research and Development at Linear Diagnostics. He added, “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.”

Collaboration for success

The NIHR HealthTech Research Center (HRC), hosted by Newcastle upon Tyne Hospitals NHS Foundation Trust in partnership with Newcastle university, will assist in evaluating the technology.

“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,” said Dr.Jana Suklan, Senior Methodologist at the HRC. “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.”

Dr. Suklan further explained, “Our research involves analyzing 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.”

“We’re delighted to have the prospect to continue our collaborative work with our partner innovators to support the development and evaluation of this new exciting test,” said John Tyson, Head of the North East Innovation Lab, part of Newcastle Hospitals. “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.”