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

[Asia Economy Reporter Lee Gwan-joo] Boditech Med announced on the 13th that it has obtained export approval from the Ministry of Food and Drug Safety for three types of therapeutic drug monitoring (TDM) diagnostic kits: 'AFIAS Free Anti-Golimumab,' 'AFIAS Trastuzumab,' and 'AFIAS Bevacizumab.'

The three approved TDM diagnostic kits are used to detect adverse reactions caused by autoimmune therapies and anticancer treatments, as well as to monitor the safety and appropriate dosage of these therapies.

AFIAS Free Anti-Golimumab is a diagnostic kit that measures the blood concentration of golimumab (product name Symphony), an autoimmune therapy used for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. AFIAS Trastuzumab measures trastuzumab (product name Herceptin), used for metastatic breast cancer and gastric cancer treatment, while AFIAS Bevacizumab measures the drug concentration of bevacizumab (product name Avastin), used in the treatment of cervical cancer, ovarian cancer, and glioblastoma.

TDM is a test that checks whether the concentration of administered drugs in the blood is within the therapeutic range and monitors the immune response occurring in the body after drug administration. As the global biopharmaceutical market experiences rapid growth in the anticancer antibody therapy sector, the demand for TDM products is also expected to continuously increase.

Choi Eui-yeol, CEO of Boditech Med, stated, “With the global increase in demand for personalized medicine, interest in the TDM diagnostic market is growing. We will target the global TDM market by developing TDM diagnostic kits that offer more accurate and convenient diagnostics than existing commercialized products.”