SD BIOSENSOR receives WHO prequalification of the STANDARD G6PD Test

The STANDARD G6PD Test, developed by SD BIOSENSOR, has achieved prequalification from the World Health Organization (WHO). This milestone marks a significant advancement in global efforts to improve malaria treatment and eliminate Plasmodium vivax (P. vivax) malaria.

Glucose-6-phosphate dehydrogenase (G6PD) deficiency, a hereditary condition affecting approximately 400 million people worldwide, poses a significant challenge to malaria case management. Individuals with G6PD deficiency are at risk of severe anemia if treated with radical cure therapies such as primaquine and tafenoquine, without prior testing. The STANDARD G6PD Test is the first portable, point-of-care diagnostic device that provides rapid, quantitative measurements of G6PD enzyme activity. It enables safer access to radical cure therapies for P. vivax malaria, which are essential for eliminating the dormant liver stage of the parasite responsible for relapsing malaria.

The test is now included on the WHO list of prequalified in vitro diagnostic products, further demonstrating its compliance with WHO’s rigorous quality standards. WHO prequalification was supported by extensive clinical studies in Brazil, Ethiopia, India, and the United States that demonstrated the clinical performance of the test.

WHO prequalification benefits both procurers and manufacturers by ensuring quality and suitability of products for their intended use. Prequalification enables manufacturers like SD BIOSENSOR to supply their products to procurement agencies such as the United Nations Children’s Fund and The Global Fund to Fight AIDS, Tuberculosis and Malaria, which adhere to strict quality assurance policies.

The STANDARD G6PD Test enables the effective treatment of P. vivax malaria by identifying people with G6PD deficiency. By offering a reliable, easy-to-use solution at the point of care, the STANDARD G6PD Test removes a significant barrier to elimination of the disease by making effective malaria treatment safer and more accessible in resource-limited settings. G6PD testing must be performed before prescribing tafenoquine and high-dose primaquine, both of which are new treatment regimens for P. vivax recommended in the recently updated WHO Guidelines for Malaria. Tafenoquine, co-administered with chloroquine, is the first single-dose medicine for the prevention of relapse of P. vivax malaria.

“Prequalification of the first point-of-care test for the diagnosis of G6PD deficiency represents a critical milestone in our efforts to bring the best curative treatment options for P. vivax to those who need them most,” said Melanie Saville, PATH’s Chief Scientific Officer. “The STANDARD G6PD Test is already being used to inform treatment of men, women, and children with primaquine regimens that were until now not safely accessible to them. Access to the first single-dose treatment option for P.vivax, tafenoquine, that was recently prequalified and recommended by WHO is also supported by the availability of this product. This achievement demonstrates the power of public-private partnerships to accelerate innovative and impactful solutions that take us closer to eliminating malaria.”

“We are delighted that STANDARD G6PD, co-developed by SD Biosensor and PATH, has become the first portable point-of-care G6PD enzyme measurement device to receive WHO Prequalification,” said HyoKeun Lee, the CEO of SD Biosensor. “This will help us quickly supply the product to countries where P. vivax malaria is prevalent. We will continue working with international organizations to raise awareness of G6PD diagnostics and contribute to advancing global health.”

The STANDARD G6PD Test was developed in a collaboration between SD Biosensor and PATH. This collaboration has included generating the clinical evidence needed to support stringent regulatory approval and achieve WHO prequalification. The handheld device provides a measure of a patient’s G6PD enzyme activity levels in two minutes based on a drop of blood from a finger prick. The test has been approved by the Australian Therapeutic Goods Administration and the Global Fund Expert Review Panel for Diagnostics and is distributed to more than 30 countries.

Tafenoquine is an 8-aminoquinoline with activity against all stages of the P. vivax life cycle, including hypnozoites. It is available in adult and pediatric formulations and is suitable for children aged 2 years and older, weighing at least 10 kg. It was first synthesized by scientists at the Walter Reed Army Institute of Research in 1978. GSK’s legacy in the research and development of tafenoquine as a potential medicine for malaria commenced more than 20 years ago. In 2008, GSK entered into a collaboration with the not-for-profit drug research partnership Medicines for Malaria Venture (MMV) to develop tafenoquine as an anti-relapse medicine for patients infected with P. vivax. Tafenoquine is currently registered in 12 malaria-endemic countries. The tafenoquine clinical program is part of GSK’s global health program aimed at improving health care for vulnerable populations.

About PATH

PATH is a non-profit organization whose mission is to advance health equity through innovation and partnerships. With a presence in 70+ countries, 40+ years of experience forging multisector partnerships, and expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales innovative solutions to the world’s most pressing health challenges.

About SD BIOSENSOR

SD BIOSENSOR is an in-vitro diagnostics company that contributes to improving the quality of life by quickly and accurately diagnosing diseases under the slogan ‘Beginning of all things that protect lives’. We have provided various diagnostic platforms to the IVD industry through the constant technological innovation such as POC Molecular Diagnostics, Fluorescent Immunoassay, Immunochromatography, BGMS. The headquarters of SD BIOSENSOR is located in Korea and, the subsidiaries are placed in the USA, Brazil, Panama, India, Indonesia, China, Germany, Italy and Spain. SD BIOSENSOR's strong point to be able to become a global top IVD company throughout the world is having around 199 distribution sales networks globally along with subsidiaries' sales channels. SD BIOSENSOR will continuously create new values by accumulating and analyzing data using AI technology as well as by offering accurate, innovative and effective diagnostics, products and services to pursue our goal of contributing to human health. To learn more about SD BIOSENSOR, please visit https://www.sdbiosensor.com/.

PATH’s work on the G6PD diagnostic was supported by grants from the UK Foreign, Commonwealth and Development Office, the Bill & Melinda Gates Foundation, and the RIGHT Foundation.