Bodytechmed Obtains Approval for Domestic First Antibody Therapy TDM Diagnostic Kit Use

Bodytechmed AFIAS Infliximab.

[Asia Economy Reporter Lee Gwan-ju] Boditech Med announced on the 2nd that it has obtained domestic approval from the Ministry of Food and Drug Safety for the therapeutic drug monitoring (TDM) diagnostic kit ‘AFIAS Infliximab’ that measures the blood concentration of autoimmune therapeutics. This is the first time that an antibody therapeutic TDM product has received domestic approval.

TDM measures the concentration of a specific drug in the blood to check whether the blood drug concentration is within the therapeutic range. The approved AFIAS Infliximab is a diagnostic kit that monitors the blood concentration of the autoimmune therapeutic agent 'Remsima/Inflectra (generic name: infliximab)', used for rheumatoid arthritis, ulcerative colitis, Crohn’s disease, and psoriatic arthritis. It checks for adverse reactions caused by autoimmune therapeutics and monitors the safety and appropriate dosage of the treatment.

AFIAS Infliximab is a point-of-care diagnostic product that allows the patient’s condition to be immediately assessed on-site just before administering the autoimmune therapeutic, enabling tailored medical treatment. Test results can be confirmed within 15 minutes at the patient’s visit location, and the available blood types have been expanded to enhance patient convenience.

Boditech Med is positioning TDM diagnostic kits for immune therapeutics and targeted anticancer therapeutics as its next growth engine. Following the launch of TDM diagnostic kits for infliximab, adalimumab, and golimumab, the company is developing TDM diagnostic kits for various autoimmune therapeutics and anticancer drugs.

Choi Eui-yeol, CEO of Boditech Med, said, “With this domestic approval, the possibility of personalized treatment for patients with ulcerative colitis, Crohn’s disease, and rheumatoid arthritis has increased,” and added, “We will develop TDM diagnostic kits for various autoimmune and anticancer therapeutics to target the global TDM market.”

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