DRW has developed a simple, point-of-care (POC) nucleic acid test (NAT) platform, called SAMBA, which allows complex, high-performance HIV tests to be carried out in doctor's offices, pharmacies and other primary and community health-care settings. SAMBA was designed specifically for use in such settings, whereas currently-used complex nucleic acid technology is not designed for use outside of complex, centralised laboratories with highly skilled staff. DRW has two CE marked tests: one for early HIV detection and one to estimate HIV viral load for treatment monitoring. The tests are currently used in remote settings in Zimbabwe, Malawi and Uganda but are equally suited to point-of-care settings in the UK and other developed countries. The proposed project will investigate how SAMBA can be integrated with NHS sites providing new preventative treatment for people at very high risk of contracting HIV. During this planning phase DRW will work with a clinical consultant in the NHS and a software engineer to identify and contact clinical sites offering this treatment. DRW together with the consultants will then plan how SAMBA results reporting can be integrated with Laboratory Information Management Systems in use and develop a protocol for evaluating SAMBA for HIV diagnosis at these sites.

"DRW has developed SAMBA, a nucleic acid test system that can be used at the point of care in rural, remote locations to test for HIV viral load for therapy monitoring and early HIV infection diagnosis in infants born from HIV+ mothers to allow for early treatment. SAMBA instrument and tests are CE-marked, allowing use in Europe and Africa. DRW needs to develop the market and is working with ministries of health in several African countries and a hospital in Ukraine to implement SAMBA. In Africa, challenges associated with governments are proving to be a slow and circuitous process. However, there are private organisations working on the ground and in need of appropriate tools to test for HIV in remote, decentralised settings. DRW is already working with Médecins Sans Frontières and this project proposes to identify and quantify additional opportunities in private health organisations, such as faith-based health providers and non-governmental organisations, while continuing to work with government organisations. An estimated 100,000 faith-based organisations (FBO) in Africa provide health care to the poor and vulnerable and may provide 20% of global HIV/AIDS work. In Uganda, FBOs provide \>25% of all health services and private non-for-profits (including FBOs) account for 41% of hospitals and 22% of lower level health facilities. These organisations are highly motivated to provide health care to people in critical need but who cannot afford it. DRW proposes to identify and engage with such organisations in African and Eastern European markets, which are currently inaccessible, and develop a business strategy for delivering SAMBA to those markets. The information gathered will be used to develop an appropriate and sustainable strategy for supplying tests to these organisations. The following information will be researched: a) identify countries, organisations and sites for subsequent implementation in 'Phase 2'; b) determine number of tests needed per year; c) determine price acceptability; d) understand test site environment, facilities and users; e) update market analysis including market size, funding mechanisms and sustainability f) update and expand DRW's commercialisation strategy based on project Phase 1 outcomes and g) if time and resources allow, perform trial implementation or training for SAMBA. Determining additional implementation channels in addition to large government programmes will expand the use of SAMBA, impacting more people's health and allowing DRW to exploit SAMBA beneficially, thereby supporting testing needs and creating a sustainable future for the company's work and the SAMBA product."

Respiratory infections cause around 4.25 million deaths worldwide every year. In the UK, many patients visit their GP for a suspected flu infection and large numbers are hospitalised. Since a flu infection shares many symtoms with a number of other infections, including the common cold, patients are often treated incorrectly. Currently, there is no simple accurate point-of-care test (POC) that can be used to quickly diagnose infections, and doctors rely on symptoms for diagnosis. The World Health Organisation has listed development of accurate POC tests for respiratory viral infections as a priority. Development of such a test may transform the way doctors assess and treat patients with acute respiratory infections. Rapid diagnosis of the virus causing the respiratory infections would allow the correct treatment to be administered, thereby reducing morbidity and mortality in at-risk groups, leading to better treatment for patients and resource and cost savings for healthcare providers. However, before such as test is developed it is critical that diagnostic manufactureres understand the clinicians requirement for the test. The objective of this project is to 1) generate understanding of the market for a POC test to diagnose respiratory infections by determining the clinical and health enconomic requirements and 2) determine the feasibility of developing the test for use on DRW's CE marked SAMBA platform. DRW will use this information to inform the development of, and reduce the financial risk of, developing an innovative multiplex diagnostic POC test for the diagnosis of respiratory viral infections.

DRW is marketing a simple, robust point-of-care nucleic acid diagnostic platform, called SAMBA, which allows complex, high-performance tests to be carried out in remote, resource-limited settings in developing countries and primary care settings in developed countries. The first SAMBA tests are for HIV: one to measure HIV viral load for treatment monitoring and one to detect HIV in infants in order to initiate early treatment. Due to WHO recommendation and international aid funding for viral load monitoring and early infant diagnosis in sub-Saharan Africa, $470 million will be available between 2017-2019 for HIV diagnostic procurement. To meet this demand, DRW must automate its test cartridge manufacture to allow a production scale of 1.5 million tests/annum. DRW proposes and requests funding for developing critical, challenging production processes that are appropriate for high-speed assembly and 100% inspection, to produce SAMBA tests for the developed and developing world market. The proposed project will further progress positive outcomes of concepts developed with support from Innovate UK for Production Line Readiness.

Diagnostics for the Real World (DRW) is marketing a simple, robust point-of-care nucleic acid diagnostic platform, called SAMBA, which allows complex, high-performance tests to be carried out in remote, resource-limited settings in developing countries and primary care settings in developed countries. The first SAMBA tests are for HIV and will be used to monitor HIV treatment in adults and infants: one to measure HIV viral load and one to detect HIV in infants. HIV treatment programs are critical in Africa to reduce the mortality and social burden of HIV there. Due to WHO recommendation and international aid funding for viral load monitoring and early infant diagnosis in sub-Saharan Africa, $470 million will be available between 2017-2019 for HIV diagnostic procurement. To help African Ministries of Health and organisations such as Médecins Sans Frontières to monitor their HIV treatment programs, DRW is proposing to develop an innovative “cloud” computer-based application (App) or “Dashboard” that would send results to a central location and give organisation the ability to analyse the data and track it for the purpose of monitoring and tracking results to help HIV treatment programs to be more effective. The system would ideally be used with SAMBA, but could be developed to allow patient results from any system to be imported into the database.

Diagnostics for the Real World has developed a simple, robust, point-of-care nucleic acid test platform called SAMBA, which allows complex, high-performance tests to be carried out in remote, resource-limited settings in Africa or primary care settings in the UK and EU. The first SAMBA tests are for HIV: 1) viral load measure for treatment monitoring and 2) HIV detection in infants to initiate early treatment. With WHO recommendation and funding from aid organisations, the market for HIV testing to monitor and initiate treatment in Sub- Saharan Africa is estimated at $470 million for 2017-2019. Initial customers will be African Ministries of Health and organisations such as Médecins Sans Frontières (MSF). To promote SAMBA, DRW proposes to initially target Kenya, Uganda, Malawi and Zimbabwe and meet with their Ministries of Health to identify how SAMBA can benefit their HIV treatment programs for mothers and newborns, people in remote villages and improved HIV results monitoring. Study results will help further develop a customer-driven implementation plan.

DRW is marketing a simple, robust point-of-care nucleic acid diagnostic platform, called SAMBA, which allows complex, high-performance tests to be carried out in remote, resource-limited settings in developing countries and primary care settings in developed countries. The first SAMBA tests are for HIV: one to measure HIV viral load for treatment monitoring and one to detect HIV in infants in order to initiate early treatment. Due to WHO recommendation for viral load monitoring and early infant diagnosis in sub-Saharan Africa, the market in the developing world alone will grow to $1 billion/annum by 2017. To meet demand, DRW must automate its test cartridge manufacture to allow a production scale of 1.5 million tests/annum. DRW proposes and requests funding for developing production processes that are appropriate for high-speed assembly and 100% inspection, to produce SAMBA tests for the developed and developing world market.

The objective of this project is to develop a new cost effectiveness tool (the 'tool'), which can be used by health commissioners and providers to assess the costs and benefits of introducing the point-of-care (POC) Chlamydia Rapid Test. Developing this tool will require: (1) the development of an appropriate dynamic mathematical model (the 'model') that captures the dynamics of Chlamydia transmission; (2) the collection of information on both: (a) behaviour of tested individuals in different settings to refine and test the proposed model and (b) changes in care pathways and associated costs and savings by using the POC Chlamydia Rapid Test. The tool will allow health commissioners and providers to populate the model with location specific data to generate outputs specific to a single clinic, health authority or regions.

The project objective is to develop a nucleic acid-based duplex test for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) for point-of-care use. The project will be carried out by a consortium, composed of Diagnostics for the Real World (Europe) Ltd. and the Diagnostics Development Unit, University of Cambridge. The expertise brought by the consortium parties covers all activities required to conduct the project: product development; scale up; validation and clinical trials in health care settings for regulatory submission. The CT/NG duplex test is based on a simple nucleic acid chemistry platform called SAMBA (“Simplified AMplification Based Assay). Simple to collect and non-invasive samples will be used, such as self-collected vaginal swabs or urine collected by FirstBurst®, a unique and patented first-void urine collection device, which collects the first 3 ml of urine containing 84% of bacteria from a urine stream. The highly stable reagents are provided in unit-dose cartridges and the results can be visually read using a patented lateral flow device. The test can be easily carried out by minimally trained personnel at point of care settings and can provide results to clinicians while the patients are still at the clinic, thus allowing immediate treatment and efficient contact tracing.