Expert Review Panel for Diagnostics approval expands access to a G6PD deficiency test that supports P. vivax malaria treatment and elimination initiatives
The STANDARD™ G6PD has achieved provisional Expert Review Panel for Diagnostics (ERPD) approval, which enables procurement with Global Fund and Unitaid funds. Point-of-care diagnostics for G6PD deficiency play a critical role in supporting appropriate treatment of Plasmodium vivax malaria and efforts to eliminate the disease.
Up to 2.85 billion people may be at risk of infection with Plasmodium vivax malaria. It is the most difficult type of malaria to fully treat because a form of the malaria parasite can lie dormant in the liver and cause relapses long after all symptoms from the first infection are resolved. P. vivax is also hard to eliminate because patients are infective during relapses, perpetuating the infection cycle. All forms of the parasite must be fully cleared from the body to completely cure a patient with P. vivax and end transmission to others. This is known as “radical cure.”
Currently, radical cure can be only achieved through treatment with specific drugs: primaquine and tafenoquine. However, prior to taking these drugs, patients must be tested for deficiency of a specific enzyme known as G6PD, which helps protect red blood cells. Patients with a G6PD enzyme deficiency could have severe adverse reactions, like hemolytic anemia, during treatment with radical cure drugs. People with G6PD deficiency could also have reactions to certain other pharmaceutical treatments and foods. It is estimated that 400 million people worldwide are G6PD deficient, and the condition is common in areas where malaria is endemic.
Until recently, simple, rapid tests for G6PD deficiency have not been widely available at the point of care (POC) for testing and treating malaria.
PATH is working with partners to develop and bring to market a portfolio of diagnostic tests for G6PD deficiency to help guide appropriate clinical care and support of P. vivax elimination.
PATH has supported the development and commercialization of the STANDARD™ G6PD, a quantitative POC G6PD test. The STANDARD™ G6PD test, manufactured by SD Biosensor, measures both G6PD activity and hemoglobin, making it easier to detect enzyme levels and determine the most appropriate plan for treating patients with p. Vivax malaria.
The STANDARD™ G6PD test just received provisional approval (effective July 2019) by the Expert Review Panel for Diagnostics (ERPD) - a group of independent experts who review the potential risks and benefits of diagnostic products that have a high public health impact that have not yet completed the WHO approval process (known as Prequalification or PQ) or review by a stringent regulatory authority. The Global Fund publishes a list of diagnostic products eligible under its quality assurance policies, including ERPD approval. This means the STANDARD™ G6PD test is now available for malaria endemic countries procuring health supplies with Global Fund or Unitaid support. Currently, the STANDARD™
Provisional approval enables procurement for a time-limited period of 12 months once procurement requests from principle recipients have been reviewed on an ad hoc basis. During that time, the STANDARD™ G6PD is expected to be submitted for World Health Organization prequalification (PQ) and United States FDA 510(k) clearance; if approved following the completion of those review processes, on-going procurement would be available.
PATH’s work on G6PD diagnostics is supported by grants from the UK Department for International Development, the Bill & Melinda Gates Foundation, and GSK.
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