STANDARD G6PD Test receives regulatory approval by the Australian Therapeutic Goods Administration

25 May 2021
Gloved hands performing STANDARD G6PD test.

Point-of-care test critical to improving the treatment and elimination of relapsing malaria receives regulatory approval.

PATH congratulates SD BIOSENSOR for the regulatory approval by the Australian Therapeutic Goods Administration (TGA) on April 21, 2021, of their STANDARD™ G6PD Test. The STANDARD G6PD Test is the first point-of-care test for glucose-6-phosphate dehydrogenase (G6PD) deficiency that can support safe access to the currently available drugs that treat Plasmodium vivax (P. vivax) malaria in both men and women. The recent approval by the TGA certifies that the test is appropriate for use in point-of-care settings and meets rigorous quality standards.  

SD BIOSENSOR developed the STANDARD G6PD Test, with PATH’s assistance, to guide appropriate clinical care of patients with P. vivax malaria who also have a hereditary deficiency of the G6PD enzyme. G6PD deficiency affects up to 400 million people worldwide and is prevalent in places where malaria is endemic. People with G6PD deficiency can experience severe anemia when taking 8-aminoquinoline drugs—the only effective means of killing the dormant form of the parasite that causes relapsing P. vivax malaria.

To avoid administering 8-aminoquinoline drugs inappropriately to G6PD deficient individuals, the World Health Organization (WHO) recommends conducting a G6PD deficiency test prior to treatment; however, to date, the only reliable tests for G6PD deficiency have been limited to laboratory-based diagnostics that require significant expertise, time, and resources to run. The STANDARD G6PD Test quickly determines on site whether a patient presenting with P. vivax infection has sufficient G6PD activity in their red blood cells to be treated with an 8-aminoquinoline drug. The recent approval of SD BIOSENSOR’s point-of-care test for G6PD deficiency expands access to malaria treatment and decision-making to locations where people initially seek health care—at primary health care facilities, dispensaries, and possibly even through trained health care workers. Regulatory approval of the STANDARD G6PD diagnostic, capable of quickly and accurately identifying G6PD deficient individuals, removes a significant barrier to simple and effective radical cure. 

“Point-of-care testing solution that can distinguish deficient, intermediate and normal levels of G6PD enzyme activity is essential to ensure patients with P. vivax malaria have equitable access to the best available treatment options. Stringent regulatory approval of the STANDARD G6PD Test is a critical milestone towards assessing the use of this test in supporting malaria case management,” states Cedric Jo, international project coordinator at SD BIOSENSOR.

“Regulatory approval of the STANDARD G6PD Test represents an exciting and important milestone toward our collective goal of reducing and eliminating P. vivax,” says Kammerle Schneider, director of the Center for Malaria Control and Elimination at PATH. “Point-of-care testing for G6PD levels is critical to improving health equity and access to safe, radical cure for all those in need.”

PATH first partnered with SD BIOSENSOR in 2016 to support the advancement of the STANDARD G6PD Test through product development and clinical evidence generation for submission to the TGA and WHO’s Prequalification of In Vitro Diagnostics Programme (PQ). The product is currently under review by WHO PQ. It is important now to evaluate how this product can fit into malaria case management workflows. Country partners are currently evaluating the feasibility of incorporating the STANDARD G6PD Test into routine case management in Africa, South America, and Southeast Asia. This work is funded by grants to PATH from the Bill & Melinda Gates Foundation and the United Kingdom’s Foreign, Commonwealth & Development Office.  

About PATH

PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. Our team of innovators comprises 1,400+ employees in offices in 20 countries. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide. We work in more than 70 countries to transform bold ideas into sustainable solutions that improve health and well-being for all, reaching more than 150 million people, on average, each year.

About SD BIOSENSOR

SD BIOSENSOR is a company specialized in IVD product development and manufacturing with the goal of contributing to improve the quality of life through fast and accurate diagnosis of disease. Since the foundation, SD BIOSENSOR has provided various diagnostic solutions such as blood glucose monitoring system, dry chemistry analyzers, ELISA, rapid test kits, fluorescent test system and molecular test system worldwide. From 2020, the company is supplying numerous diagnostic products that are WHO prequalified for the global public health, especially for malaria, HIV, HCV, and COVID-19. To learn more about SD BIOSENSOR’s products, please visit http://en.sdbiosensor.com/xe/.

This story was originally published by PATH.