Health Diagnostics

Quimin You of Ustar Biotechnologies (Hangzhou) Ltd. in China will develop affordable, rapid, and simple nucleic acid extraction devices and an affordable, rapid and simple isothermal nucleic acid amplification assay that can be performed at the village level by minimally trained personnel.

Nguyen Trung and Nguyen Van Kinh of the National Hospital for Tropical Diseases in Vietnam will develop a patient­to­chip microfluidics component for the collection and processing of whole blood into plasma and cells for downstream testing to target highly prevalent tropical diseases.

Chandrasekhar Nair of Bigtec Labs in India aims to create a low-cost, reliable, automated sample preparation system that can be interfaced with nucleic acid detection techniques such as real-time polymerase chain reaction (PCR) and Loop-Mediated Isothermal PCR (LAMP), thus enabling molecular diagnosis at the point-of-care. The technique involves the creation of a device to extract pathogenic DNA/RNA from biological samples such as blood, sputum, urine, and nasal/throat swabs.

Dhananjaya Dendukuri and colleagues at Achira Labs in Inida are developing weaving as a platform for the manufacture of Fabchips (Fabric chips) that can be used to perform low­cost, rapid and multiplexed diagnostic tests. Textile weaving is a mature process that can help make reagent­functionalized chips in a convenient, affordable and scalable manner.

Achilles Katamba and investigators from Makerere University, Northwestern University, the Indian School of Business and the University of Chicago are pioneering a methodological approach to inform the design of point-of-care diagnostic platforms and create a decision support tool to enable implementation of these platforms once they become available.

Regulatory approval for diagnostics is costly, lengthy and lacks transparency in many countries. It is seen as a major barrier to innovation and access. This project seeks to survey the regulatory landscape and develop a clearly defined set of standards and a critical path for streamlining the approval of a new generation of diagnostics that are affordable, easy to use and work on plug-and-play type devices.

Regulatory approval for diagnostics is costly, lengthy and lacks transparency in many countries. It is seen as a major barrier to innovation and access. We seek to survey the regulatory landscape and develop a clearly defined set of standards and a critical path for streamlining the approval of a new generation of diagnostics that are affordable, easy to use and work on plug-and-play type devices.

Wendy Stevens of the National Health Laboratory Service and the University of Witwatersrand will lead a multi­ disciplinary team to assess the safety, cost effectiveness and impact on clinical outcome of implementing point­of care testing for HIV and tuberculosis in several different clinical settings in South Africa. The aim is to create a sustainable vehicle for future point­of­care evaluation and expansion and to provide sufficient information to inform national policy decisions, bearing in mind the need for equity, affordability and accessibility.

Transforming the classic blood capillary tube into a diagnostic device that integrates whole blood collection with molecular testing. Capillaries are fabricated with ‘hydrogel’, an acrylamide gel that includes reagents for detection of malaria and other infections. The device will provide novel diagnostics at point-of-care.

Dr. Francis Nano will lead this project in coordination with Dr. Tatyana Hamilton, who will coordinate activities with scientists in Russia.