Linear Diagnostics is currently engineering an affordable, precise, and point-of-care diagnostic platform. The aim is to achieve faster infection diagnosis from a single sample than any existing commercial alternative.

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

Linear’s Exponential Amplification (EXPAR) technology identifies bacterial DNA using a rapid signal amplification method. This technology, developed and tested at the University during the COVID-19 pandemic, was detailed in Proceedings of the National Academy of Sciences. The company has demonstrated its ability to detect bacterial STIs, urinary tract infections, and viral infections, including SARS-CoV-2, in as little as 5 minutes.

The company’s recent focus has been on STIs, particularly Neisseria gonorrhoeae and Chlamydia trachomatis, due to the increasing global concern over multi-drug-resistant strains.

Rapid testing is crucial in preventing the spread of infection, enabling patients to receive a diagnosis and begin treatment during a single clinic visit.While current tests may be user-amiable and require minimal training, existing technologies have struggled to meet the 20-minute sample-to-result target.

The new funding will allow Linear to finalize the design of a cartridge and reader platform and validate its performance.

Executive Insights

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.”

“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 play a key role in evaluating 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 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.”

John Tyson, Head of the North East Innovation Lab, part of Newcastle Hospitals, said: “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. 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.”