Wells Bio said on Thursday that it obtained medical device approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for its careSTART G6PD Biosensor Analyzer.

Accordingly, the company will begin exporting the device to Japan this month.

The biosensor analyzer is a medical device that utilizes enzyme immunoassay technology to diagnose glucose-6-phosphate dehydrogenase (G6PD) deficiency. It works by quantitatively measuring the concentration of G6PD through an enzymatic reaction that occurs in human blood.

It is the world's first diagnostic developed to provide quantitative test results of G6PD in just 4 minutes, the company said. It is also portable and easy to use.

G6PD deficiency is the most common enzyme deficiency with an estimated 400 million patients worldwide.

Individuals with G6PD deficiency may experience symptoms such as anemia, jaundice, fatigue, and shortness of breath. This is because their red blood cells are easily destroyed by infections or certain medications.

The G6PD enzyme plays a key role in maintaining the stability of hemoglobin and ensures the sustainable transport of oxygen in the blood. Particularly, it is important to measure G6PD levels when a patient with a deficiency is prescribed medication after malaria infection or high-dose vitamin C injections, as side effects such as acute hemolytic anemia can be severe and even fatal.

G6PD deficiency is highly prevalent in Africa, Southeast Asia, the Middle East, and Mediterranean and South Pacific islands. Additionally, recent population migration has resulted in an increasing number of patients in North and South America and Northern Europe, which is expected to drive growth in these diagnostic markets.

"The G6PD test is a versatile test that can aid the prescription of malaria drugs, and also help diagnose neonatal jaundice and congenital hemolytic diseases," said a Wells Bio official.

He also mentioned that in Japan, vitamin therapies were popular for promoting recovery after plastic surgery procedures and preventing skin aging, which has led to an increased demand for G6PD diagnostic tests before such treatments.