<a href="https://gcgh.grandchallenges.org/challenge/point-care-diagnostics" target="_blank" rel="noopener noreferrer">Grand Challenges in Global Health launched a new grant program</a> to create technologies to assess health conditions and pathogens at the point-of-care in a variety of settings, building on the <a href="https://gcgh.grandchallenges.org/challenge/develop-technologies-allow-assessment-multiple-conditions-and-pathogens-point-care" target="_blank" rel="noopener noreferrer">challenge</a> funded in 2005. $30 million in funding was committed for Phase I of this new diagnostics program. In coordination with this new program, Grand Challenges Canada launched a new point-of-care diagnostics grant opportunity directed primarily at researchers in low- and middle-income countries. $12 million Canadian in funding is available for this initiative. Together these initiatives aim not only to develop and implement new technologies, but also to define standards for point-of-care diagnostics that would enable a single instrument to perform numerous diagnostic tests, thereby reducing cost and complexity within the healthcare system.

Grand Challenges in Global Health launched a new grant program to create technologies to assess health conditions and pathogens at the point-of-care in a variety of settings, building on the challenge funded in 2005. $30 million in funding was committed for Phase I of this new diagnostics program. In coordination with this new program, Grand Challenges Canada launched a new point-of-care diagnostics grant opportunity directed primarily at researchers in low- and middle-income countries. $12 million Canadian in funding is available for this initiative. Together these initiatives aim not only to develop and implement new technologies, but also to define standards for point-of-care diagnostics that would enable a single instrument to perform numerous diagnostic tests, thereby reducing cost and complexity within the healthcare system.

Point-of-Care Diagnostics

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Grand Challenges Canada Diagnostics Initiative

Grand Challenges Canada: Point-of-Care Diagnostics

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.&nbsp; 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. 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.&nbsp; 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.

Improving Regulatory Oversight of In-vitro Diagnostics in the Developing World

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.

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.

Integrated Innovation Approaches to Point-of-Care Diagnostics Regulation Harmonization

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.

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.

Optimization and Evaluation of Flocked Swab Transport Systems for the Identification of Enteric Pathogens

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.

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.

Implementation Research for Point-of-Care Diagnosis of Visceral Leishmaniasis in India

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.

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.

Development of a Hand-held, DNA Aptamer-based Surface Enhanced Resonance Raman Scattering (SERS) Biosensor for Direct Identification and Quantitation of Biomarkers and Pathogens in Complex Biological Samples at Point-of-Care