EasyDiatech Receives Domestic Approval for Blood-Based Concussion Diagnostic Kit

In vitro diagnostics company EasyDiatech announced on the 12th that it has obtained domestic approval from the Ministry of Food and Drug Safety for the diagnostic reagent ‘VEUPLEX™ TBI assay,’ which can quantitatively measure the diagnosis of traumatic brain injury patients through their blood.

The VEUPLEX™ TBI assay simultaneously tests two specific biomarkers that enable the diagnosis of traumatic brain injury from blood in about 50 minutes. It allows for rapid diagnosis of mild traumatic brain injury and concussion patients.

Head CT scans have mainly been used to diagnose mild brain injuries caused by various external impacts such as falls, sports, and traffic accidents. However, the detection rate was about 10%, showing limitations in quantitative measurement. Approximately 15% of concussion patients who did not receive appropriate treatment suffered from severe aftereffects for more than a year.

The ‘VEUPLEX™ TBI assay,’ tested on the in vitro diagnostic platform ‘VEUDx’ analyzer utilizing precise fluorescent immunoassay, recently demonstrated excellent detection capability with a sensitivity of 99.15% in clinical trials conducted in collaboration with Seoul National University Hospital.

EasyDiatech, established in 2016, is a specialized company in in vitro diagnostic medical devices. It independently developed the ‘VEUDx analyzer,’ a high-sensitivity multiplex in vitro diagnostic platform device with versatility and rapidity.

Jung Yong-gyun, CEO of EasyDiatech, said, "We are able to introduce an innovative and accurate blood diagnostic kit for concussion," adding, "It will enable rapid and precise diagnosis of more than 300,000 concussion patients occurring annually."

This content was produced with the assistance of AI translation services.