Sugentech, MFDS Approval for Blood-based Tuberculosis POCT Kit

Diagnosis of 'CFP-10' markers in blood that secrete tuberculosis bacteria...Sensitivity 85%-Specificity 96%. Full-scale overseas advancement, including clinical progress in China

Up until now, tuberculosis can be diagnosed as gossip from suspected patients, making it difficult for the elderly and the weak to extract gossip difficult to diagnose correctly and quickly due to infection and pollution caused by gossip.

Sugentech has pushed to develop kits to diagnose tuberculosis, confirming clinical performance in clinical trials in Korea earlier this year. As a result, it has secured 85% sensitivity and 96% specificity. Sensitivity is an indicator of whether a disease is identified exactly when it occurs and when it is not.

"Tuberculosis diagnosis through previous conversations was only irregular at 70% to 90%, and it took a long time to check the results at the bio-safety laboratory (BL2)," said an official at Sugentech. "Sugentech is differentiated by the fact that it is possible to diagnose immediately at medical sites with blood."

Sugentech plans to carry out the evaluation of neuroscience technology by first selling it to the market through the "advanced in-and-post assessment of the field of in vitro diagnosis examination of infectious diseases" introduced earlier this year as part of the government's regulatory reform.

The company is currently conducting clinical trials in China as well, and is also pushing for additional clinical trials in two Southeast Asian countries. Sugentech also won the European CE certification early this year. The company plans to challenge the global diagnostic market by proving its clinical performance through these multi-state clinical trials.

"By successfully commercializing the blood-based tuberculosis diagnosis kit, which has long been needed at medical sites, we can create new markets as well as alternatives to the existing tuberculosis diagnosis market," said Son Mi-jin, CEO of Sugentech.