Genetic Microdevices Ltd has developed a small device - the QbQ chip- that can analyse proteins in blood with unprecedented sensitivity, speed and cost. The chip can detect minute amounts of disease biomarkers in less than 15 minutes for a cost that resembles that of Lateral Flow Assays. Once the QbQ test chip becomes available it will revolutionise Point-of-Care testing. It will enable detection of conditions that carry biomarkers in blood, much earlier than is currently possible. For example early detection of Dementia can massively improve therapeutic outcome, since for the first time there are drugs available that treat Alzheimer's at its cause to slow down neurodegeneration. Similarly in Cardiovascular disease, detecting low levels of biomarkers that are trending up in blood can create a much more accurate risk profile for future illness. The same is true for cancer biomarkers where early detection is absolute key for therapeutic outcome. However the ability to detect disease much earlier must be accompanied by high speed and low cost per test. Because only then, can screening processes in the NHS become viable. The QbQ system has already demonstrated its superior performance in our lab. What remains to be done is to create a small benchtop machine that is close to a commercial form and validate it with our collaborators in two assays: One for cardiovascular disease and one for dementia. Once the technology is validated it will be ready for early deployment in academic settings to accelerate development of advanced diagnostic panels for Dementia, CVD, Cancer and many other conditions. Ultimately we shall further develop those tools into fully certified diagnostic tools for the Point-of-Care. At that point the QbQ will be placed in hospitals, universities, pharmacies, and GP's for testing of a wide spectrum of conditions. The project is deeply collaborative, it brings together Genetic Microdevices, The Great Ormond Street Institute for Child Health and Centre for Process Innovation. This wealth of know-how ensures optimal delivery of the technology to the patient.

The onset of the SARS-COV- 2 pandemic and subsequent lockdown created significant economic and social disruption worsening inequality, unemployment, community tensions and straining the NHS. The easing of the lockdown, currently underway, has reinforced the need to prevent an increase in new infections, to avoid another lockdown with its adverse economic, educational and social effects. One key ingredient of the solution is cheap, fast, accurate, widely distributed, casual testing, at schools, surgeries, hospitals, nursing homes, pharmacies, testing centres, sports/entertainment events and the work place. Existing testing technologies are not suitable for these needs. Existing tests such as qPCR and antigen, fail to tick critical boxes of performance. qPCR takes long and requires expensive reagents. It is not ideal to be used at the point of care. Antigen tests are not sensitive enough and often the sepcificity suffers. Genetic Microdevices Ltd has the best technology in the world for detecting both active infections and past exposure to infection. We are proposing a 9 months project to validate two serological tests: \*A Test, to check past infection \*A Test to check active infection Our technology, the QbQ (cubic) can handle whole blood and swab samples, can work with minimal amounts of sample (one droplet), features very high sensitivity, 5-15 mins running time, high throughput, adaptability to mutations and low running costs and gives quantitative results. QbQ is based on a miniature test chip and eventually the whole Reader + Chip can be of handheld size. It benefits, in terms of cost and scaling up for use, from being based on a platform technology, that utilises standard materials and components, and that requires small amounts of abundant, inexpensive reagents per test. Our technology is the only one that combines all the right features, to allow it to provide cost effective, accurate, reliable tests that can be widely deployed in venues ranging from hospitals, clinics, surgeries and clinical trial centres, to universities and schools, to workplaces, and entertainment/sports facilities and are ideal for , democratised test to be deployed everywhere, at schools, in the workplace and in hospitals, to monitor accurately actively infected people and people with past infection who may have developed immunity. We believe that our technology can be a key part of the solution to reversing the disruption and exclusion caused by this and any future pandemic. Our proposal if granted, will support GMD's efforts to validate its technology that will help alleviate the pandemic's impact on the UK. By partially replacing the shortfall in funding caused by the pandemic it will enable GMD to replace the loss of a key member of the team allowing it to continue the timely planned development and validation of an innovative diagnostic platform for the SARS-COV-2 virus. Finally our technology is well suited to take part in green circular economy, as our disposable chips can be recycled to plastic or to fuel, using existing UK services.

Genetic Microdevices Ltd has developed a revolutionary next generation device that analyses biological samples such as DNA, RNA and proteins with ultra-high performance. The device is based on a disposable plastic chip (CycloChipTM) that performs the analysis. Against competitors, the technology has demonstrated 10x higher resolution, 270x higher throughput and extremely high sensitivity to small biological samples. We propose to build a CycloChipTM that performs parallel processing of four samples concurrently. This Proof-of-Concept device will be the precursor for a massively parallel chip that will make a substantial impact in high throughput biological analysis. The CycloChipTM presents significant competitive advantages. These are leveraged further by adding ultra-high throughput parallel sample processing. For example, the huge advantage of the CycloChipTM in DNA sequencing is the very high read length for sequencing individual DNA fragment templates. Our technology has a maximum read length that exceeds 1300 bases, while competing high throughput sequencers can only sequence up to approximately 300 bases at a time. This means that our technology requires far less computing power (minutes as opposed to days) to reconstitute entire genome sequences, when operated in a massively parallel regime. Similar gains are also expected in high throughput RNA and protein analysis. The proposed device will enable ultra fast, cost effective, portable devices that will increase the efficiency of NHS, help bring new drugs faster to the patient and enable diagnostic devices for early identification of hereditary disease such as cancer. Therefore the proposed funding is expected to leverage a revolutionary analytical concept into the massively parallel analysis realm and help the UK medical device industry to establish a dominant global position.

Genetic Microdevices Ltd has developed a disruptive technology that analyses proteins and DNA with ultra-high performance. The device is based on a disposable analysis chip (CycloChipTM) . Protein and DNA analysis are central to many bio-analytical procedures used widely in drug development, research and diagnostics. Our device encompasses unique intellectual property which makes it far more potent than any existing eletrophoresis based analytical systems. The technology will accelerate the development of new drugs, it will offer tools to test the compatibility of drugs with patient's genetic group, enable early diagnosis of chronic disease and improve the efficiency and quality of NHS analytical services. The increased capability of the CycloChip in a potentially portable reader device, will enable GPs to perform powerfull blood and tissue tests at their clinic or at point of care. Over the last 4 years we have developed a proof-of-concept instrument that has demonstrated most of the advanced analytical specifications. Further development is needed to improve the quality and consistency of the system. We propose to further develop the technology over 24 months into a prototype that can be converted directly into a certified product.