Boditech Med said Monday it obtained regulatory approval for AFIAS Infliximab, a monitoring device for infliximab-treated patients.

AFIAS Infliximab is a therapeutic drug monitoring (TDM) diagnostic kit to measure the level of infliximab, an autoimmune disease drug, in the blood.

It is the first time that an antibody treatment TDM product won the license in Korea.

According to Boditech Med, AFIAS Infliximab can monitor infliximab levels in the blood in patients with autoimmune diseases such as rheumatoid arthritis, ulcerative colitis, Crohn's disease, and psoriatic arthritis.

The device checks adverse reactions after administering the autoimmune disease treatment and monitors the safety and the appropriate dose.

The company said the device allowed patients to check the test result within 15 minutes and expanded the available blood types.

In the past, a patient’s sample had to be collected to check infliximab levels in the blood before administering the treatment. Then, after one or two weeks, the patient could check the result and receive the treatment.

Earlier, Boditech Med released TDM diagnostic devices for monitoring adalimumab and golimumab. In addition, the company is developing TDM devices for various autoimmune disease drugs and anticancer treatments.

Boditech Med CEO Choi Eui-yeol said the latest approval for AFIAS Infliximab raised the chance of customized treatment for patients with ulcerative colitis, Crohn's disease, and rheumatoid arthritis.

“By developing TDM diagnostic kits for various autoimmune disease treatments and anticancer drugs, we will tap the global TDM market,” he added.

TDM refers to a test of whether a certain drug’s level in the blood is within the treatment range.

According to the National Institute of Medical Device Safety Information, the global TDM market is expected to grow from $2.56 billion to $8.32 billion in 2024.