54731Rapid Point-of-Care Diagnostic Device for COVID-19ClosedFeasibility StudiesInnovate UKGB Electronics (UK) ltd., (GBE), a design-led manufacturing UK based SME is working with Brunel University London (BUL) to help them bring to market their low-cost and portable smart molecular diagnostic platform for the detection of SARS-CoV-2 (Covid-19). Prior to the Coronavirus Pandemic, an early stage version of the product was being developed by a research team led by BUL in collaboration with the University of Lancaster and the University of Surrey and intended to be used for detecting viral pathogens in poultry, funded by the Biotechnology and Biological Science Research Council (BBSRC). The research team established that with some modification their product could use a Loop Mediated Isothermal Amplification (LAMP) assay to detect COVID-19 directly from a patient sample (nasal or throat swabs) within 30 minutes. Another strength of their design was that it analysed six samples per cycle and was being specifically developed for low-cost deployment in the developing world. A set of eight early stage products are currently undergoing laboratory and clinical validation studies at NHS Laboratories. The results of which will be used to further optimise the diagnostic algorithm and the physical design of the product. GBE will then assist with the manufacture of a batch of beta products, which will be a design iteration based on the initial trial units. This increases the amount of clinical trial data available and will provide essential feedback on the functionality of the product. The beta units will then undergo a significant 'cost-down' design for manufacture stage in order to prepare for mass production. This stage will involve refinement of the hardware, firmware and mechanical design plus development of a robust communications protocol. It will be manufactured in-house at GBE's Sussex based factory. All work will be carried out in conjunction with Brunel and their team in order to optimise the efficacy of the product. Whilst gathering additional functional data we will also prepare detailed market analysis to maximise the global and industrial potential of the product. With a keen focus on the needs of the developing world, where product cost is vital. GBE has over 30 years' experience of embedded product development and manufacturing. This includes a very successful track record within the healthcare market plus experience of working with innovative product launches and solutions. Development of the product, now called the Virus Hunter 6 ( VH-6), has been at an accelerated pace. This has been along with the exponentially growing public need for a rapid point-of-care Covid-19 diagnostic device. We had the opportunity to accelerate development and allocate resources to this project, however this had meant the grant was quickly used and GBE has also funded additional work over the last 6 months. This was also in part due to the cutting edge aspects of this project, plus the constantly changing requirements: this Pandemic has seen the world enter very challenging times and all efforts are focused on dealing with this ‘new normal’. The design path has had to be extremely flexible as both the science (of the virus and its propagation) evolve along with the national and international response to it are changing on an almost weekly basis. Four key new deliverables have been identified which will have a significant impact in the rapid development and deployment of this Covid-19 detector. These are to be carried out over the next three months and will also include a real-life controlled trial of 1,500 tests at University of Surrey (for current students and employees) vs a gold standard PCR. Success will lead to expanding this to all of Surrey and Brunel University London (over 30,000 students and employees). Data gathered will be instrumental to rapid deployment of the product - enhancing its functionality and providing additional data for new scientific publications. Alongside this, we have an opportunity for smaller real-life controlled trials.