Awards

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. We will work closely with product standards setters, departments of health, the diagnostic industry, regulatory authorities and regional harmonization working parties to develop a transparent model framework for rapid and efficient approval of this novel class of diagnostics, and for the harmonization of regulatory processes in the developing world to ensure that patient needs are met in all resource settings. The second phase of the project is to develop and pilot a streamlined and harmonized regulatory process for the approval of a point-of-care (POC) IVD.  We will combine scientific, technological, social and business innovations to seed regulatory reform. We will work with regional harmonization working parties as implementing partners to focus on four potential areas of harmonization: 1) a Standard Technical Document (STED) for registration of POC IVDs; 2) convergence of standards for quality audits of POC IVD manufacturing sites: 3) a mechanism to reduce duplication in clinical trials for validating the performance of a POC IVD; 4) a system for post-marketing surveillance. The project will deliver a set of harmonized regulatory standards and project outcomes will be disseminated for adoption by regions and countries.

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. It will work closely with product standards setters, departments of health, the diagnostic industry, regulatory authorities and regional harmonization working parties to develop a transparent model framework for rapid and efficient approval of this novel class of diagnostics, and for the harmonization of regulatory processes in the developing world to ensure that patient needs are met in all resource settings.

The objective of this Botswana-based collaboration led by Dr. David Goldfarb was to design and evaluate a user-friendly flocked-swab specimen collection system for the identification of enteric infections. This would have immediate impact in much of the world where diarrheal disease remains deadly and for the large part undiagnosed. Using an inexpensive innovation in specimen collection, the team diagnosed previously unrecognized pathogens that had caused the severe diarrhoea of over one-third of children in a group of southern African hospitals. McMaster University researchers designed and tested in Botswana a specially-designed "flocked swab" for collecting samples from children admitted to hospitals with severe diarrhoeal disease. The flocked rectal swab eliminates the wait and biohazard involved in obtaining and transporting a bulk stool (faeces) sample from an infant or child. This efficiency enabled implementation of a randomized clinical trial evaluating same-day diagnosis and treatment for a broad number of pathogens – the first study of its kind anywhere.

Ann Vinckier and colleagues at QIAGEN in the U.S. propose to further improve their commercially available small fluorescence tube scanner for its use at the point-of-care in developing countries, and also investigate probe-based isothermal amplification technologies for the development of fast, sensitive, specific and robust detection of nucleic acids in point-of-care diagnostic tools.

Pradeep Das of Rajendra Memorial Research Institute of Medical Sciences in India will determine how to ensure that people with Visceral Leishmaniasis, a neglected infectious disease of poverty in Bihar, India, receive the necessary point-of-care diagnosis needed to receive treatment and save lives. Many people die from this disease because they do not receive the available diagnosis and treatment.

Jonathan Blackburn of the University of Cape Town in South Africa will use tuberculosis as a model disease to develop a low-cost, hand-held biosensor that combines the selectivity of antigen-specific DNA aptamers with the exceptional specificity of Surface Enhanced Raman Spectroscopy in order to reliably quantify pathogen biomarkers present in patient specimens at the point-of-care.

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.

Besik Kankia of the Ohio State University in the U.S. proposes to develop isothermal amplification of nucleic acids using a simple fluorescence detection method. If successful, the fluorescence signal will be detected by a portable fluorimeter or by eye after excitation with an appropriate light source.

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.

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.