Overview
Following the COVID-19 pandemic, there is an urgent need for point-of-care diagnostics that match the accuracy of lab techniques. ProtonDx (PDx), a spinout from Imperial College London (Imperial), is developing a disruptive Lab-on-Chip diagnostic technology. Through Royce’s Industrial Collaboration Project (ICP), ProtonDx successfully integrated a screen-printed material and deposition of a bio-reagent on a microchip to demonstrate 10-well pathogen multiplexing on a single cartridge. This platform has the potential to transform the diagnostic landscape in the UK and in remote settings.
About the Project
Clinicians and health professionals still lack efficient diagnostic technology to rapidly identify the source of respiratory infections and administer adequate treatment. Lateral flow tests are portable by struggle to detect low viral loads and multiple targets.
Lab-based nucleic acid tests remain the gold standard but are costly and time-consuming, extending hospital stays and burdening NHS resources. An affordable front-line test is urgently needed to rapidly and accurately identify respiratory pathogens in emergency departments and primary care.
ProtonDx (PDx) has developed an innovative diagnostic technology called ‘Lacewing’, which enables sample-to-result detection at the point-of-care, without the need for a laboratory.
The approach relies on microfluidics for ultra-pure sample extraction, high-sensitivity isothermal molecular chemistry, and electrochemical sensors for nucleic acid detection, all integrated into a single-use cartridge. The detection is enabled by a custom microchip that integrates 60,000 electrochemical biosensors within 96 mm2 to provide real-time identification of multiple targets in 10 chambers, as opposed to standard optical readout methods which are often costly and bulky.
These innovations make Lacewing truly portable, enabling the detection of a wide range of infectious diseases in under 15 minutes. The first cartridge will be aimed at 8 respiratory pathogens including SARS-CoV-2, influenza and rhinovirus.
With support from the Royce Industrial Collaboration Programme and in collaboration with Imperial College London, this project has allowed PDx to lead key industrial research and establish new processes to prototype the Lacewing cartridge for manufacturing at scale. This newly acquired knowledge has allowed PDx to identify the full Lab-on-Chip assembly workflow:
Integration of the reference electrode on-chip to greatly improve robustness and manufacturability.
Deposition of biochemicals and biomaterials on the chip surface for a panel of disease, enabling storage without a cold chain.
With support from Royce and external partners, PDx validated the compatibility of the process with the biosensors, delivering the final cartridge design and supply chain strategy that can be taken further with follow-on funding and investment, to demonstrate impact in the field of point-of-care diagnostics.
These deliverables mark key milestones Pax’s product plan as they prepare to transition the prototype to a market-ready product, lead validation with world-leading clinical partners, and seek medical device certification for a product launch in 2025.
Collaborators
ProtonDx, a spin-out from Imperial College London, builds on several years of innovative research in diagnostics and sample extractions, fuelled by unique collaborations between engineering, medicine and molecular biology.
The work was enabled through use of the facilities at Imperial College London and due to a grant from the Henry Royce Institute’s Industrial Collaboration Programme.
"The work carried out by PDx will generate rapid impact following Royce support of key research. By enabling portable, accurate and rapid diagnostics at the point-of-care, Lacewing will empower NHS clinicians with a cost-effective tool for diagnosing patients directly in the emergency department or primary care settings. This will improve patient outcomes, alleviate the burden on the NHS, and become the first line of defence against the ever-growing global threat of antimicrobial resistance, which is estimated to cause up to 10 million deaths each year by 2050."
Nick Moser
Chief Technology Officer, ProtonDx
