Diagnostic Technologies

G6PD Project


Project overview

Photo: PATH/Siri Wood.

Glucose-6-phosphate dehydrogenase (G6PD) deficiency is a hereditary disease characterized by abnormally low levels of the enzyme G6PD. This metabolic enzyme helps break down carbohydrates into usable energy and helps protect red blood cells against oxidative damage. Individuals with G6PD deficiency may exhibit hemolytic anemia, a condition that is characterized by a lack of red blood cells, due to oxidative stress in response to a number of causes, including infection or exposure to certain medications. G6PD deficiency is the most common enzyme deficiency in the world, affecting more than 400 million people worldwide, and a majority of those people live in malaria endemic areas. There are two types of malaria that are commonly found across the globe: Plasmodium vivax (P. vivax) and Plasmodium falciparum (P. falciparum). Of these two types, P. vivax is much harder to eliminate than P. falciparum; and coupled with the fact that 2.5 billion people are at risk of P. vivax infection, it has become a major obstacle for malaria elimination worldwide.

Needs

8-aminoquinoline-based drugs such as primaquine are the only current medical treatment for P. vivax radical cure (killing all malaria parasites in the body, specifically those in the liver, thus eliminating any chance of relapse) and malaria transmission. However, these drugs may cause potentially lethal acute hemolytic anemia in patients with G6PD enzyme deficiency. Best practice requires that people with G6PD enzyme deficiency do not get treated for radical cure with 8-aminoquinolines. For safe use of 8-aminoquinoline drugs, there is an essential unmet need for a reliable test of G6PD deficiency as a point of care diagnostic.

Goals

PATH aims to ensure the availability of a quality point-of-care test for G6PD deficiency whose characteristics ensure safe access to and best clinical practice for treatment of patients with P. vivax malaria.

Approach

To do this, PATH is working with key diagnostic developers and stakeholders around the world to develop point-of-care diagnostic test for G6PD deficiency. In order to guarantee a successful launch of the diagnostic, PATH has identified three areas to focus our efforts:

1. Support product developers in the development of quality point-of-care tests for G6PD deficiency.

2. Support evaluation and registration of diagnostic products for G6PD deficiency that support radical cure of patients infected with P.vivax.

3. Ensure a successful launch of the G6PD point-of-care test(s) in malaria endemic countries through targeted operational and market research.

Status

PATH is currently supporting the evaluation existing commercial G6PD tests in three malaria endemic countries. PATH has developed a target product profile for a diagnostic test for G6PD deficiency that supports radical cure of patients with P. vivax. PATH is currently seeking diagnostic developers to partner with in order to create a point-of-care test for G6PD deficiency that fits within our product specifications. PATH is establishing a specimen panel to support early development of the diagnostic product by developers. PATH is also collecting relevant operational and market research data in order to ensure a successful launch of a point-of-care G6PD diagnostic.

Next steps

We also will engage and select diagnostic developers to develop point-of-care diagnostic tests for G6PD deficiency. PATH will support the evaluation of diagnostic test as they become available in the market. Lastly, PATH will host workshops in target countries to assess market readiness and barriers to entry.

Project resources

Background

Communications

Publications

Contact

Contact the G6PD Team
Gonzalo Domingo, Project Lead
dxinfo@path.org

Contact PATH’s Seattle headquarters
Tel: 206.285.3500
Fax: 206.285.6619

 

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