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Boditech Med develops two types of companion diagnostic kits and signs a long-term supply agreement

We are proud to share the news that Boditech Med developed two types of companion diagnostic kits: AFIAS Total Anti-Infliximab and AFIAS Infliximab and to announce the long-term agreement with Celltrion Healthcare to supply the products along with two AFIAS analyzers.

The companion diagnostic kits are used for therapeutic drug monitoring (TDM) after the prescription of infliximab to treat autoimmune disorders. By regularly checking the internal drug and antibody response after administration through the tests, the efficacy and safety of the treatment can be maximized.

AFIAS Infliximab helps with TDM by measuring the level of the drug in the blood. Using whole blood, serum or plasma, the test predicts patients’ response to the drug, enabling customized treatment for each case. With AFIAS Total Anti-Infliximab, a small amount of serum or plasma is used to detect anti-drug antibodies (ADAs) to infliximab within 30 minutes. Using these tests, clinicians can determine the course of treatment for different patients.

Boditech Med has focused on developing these products since 2019 as an effort to secure momentum for further growth. The company obtained export permits for the two companion diagnostic kits from the Ministry of Food and Drug Safety in December last year.

Areas that will be supplied with the products through the agreement encompass Europe, North America, and Japan. The supply to Europe, which is a major market for infliximab products, is scheduled to begin in the first half of this year. To this end, the company completed the CE certification process for the two products last November. It plans to obtain licenses and start supplying to the other two areas in the future.

Choi Eui-yeol, CEO, Boditech Med said, "with the existing diagnostic kits, it took one to two weeks to get test results, which is limited in finding out the optimal timing for injection. Our companion diagnostic kits with short turnaround time enable the identification of the right dose cycle for each patient." Furthermore, a company official said that “the supply agreement with Celltrion Healthcare is a vital bridgehead for entering the companion diagnostics market. Companion diagnostics would not only increase the level of patient satisfaction but also be advantageous to the drug approval processes. As the market for therapeutic antibodies is expanding rapidly, it is expected that the demand for companion diagnostics will continue to increase. These new products, therefore, will be a pillar of the company’s sustainable growth."