Bodytechmed Obtains MFDS Export Approval for Four Therapeutic Drug Monitoring Diagnostic Kits

[Asia Economy Reporter Lee Gwanju] Boditech Med announced on the 16th that it has additionally obtained export approval from the Ministry of Food and Drug Safety for four types of Therapeutic Drug Monitoring (TDM) diagnostic kits.

The newly approved TDM diagnostic kits are 'AFIAS Vedolizumab,' 'AFIAS Free Anti-Vedolizumab,' 'AFIAS Etanercept,' and 'AFIAS Free Anti-Etanercept.'

'AFIAS Vedolizumab' is a diagnostic kit that measures the blood concentration of vedolizumab (product name: Entyvio), administered to patients undergoing treatment for severe active ulcerative colitis or Crohn's disease. 'AFIAS Free Anti-Vedolizumab' is a diagnostic kit that measures whether antibodies are produced due to immune response after vedolizumab administration.

Additionally, 'AFIAS Etanercept' measures the blood drug concentration of etanercept (product name: Enbrel), administered to patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and psoriasis. 'AFIAS Free Anti-Etanercept' measures whether antibodies are produced due to immune response after etanercept administration.

TDM is a test that verifies whether the drug concentration is within the therapeutic range after administration and whether an immune response has occurred. Boditech Med has developed and is supplying TDM products that reduce the testing time for blood drug concentration and immune response confirmation from three weeks to 12 minutes. While maintaining clinical performance at a level similar to existing methods, the time reduction enhances patient convenience.

Choi Eui-yeol, CEO of Boditech Med, stated, “With this additional export approval, the TDM business is gaining momentum. We will strive to become a leading global TDM company by emphasizing patient convenience and product accuracy through active marketing activities and securing additional suppliers.”

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