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Acquired approval for domestic use of ichroma™ IGRA-TB for Tuberculosis (TB) diagnosis from MFDS

We are pleased to announce that ichroma™ IGRA-TB has obtained approval for domestic use from Ministry of Food and Drug Safety (MFDS). It can diagnose the latent TB within 15 minutes.

Tuberculosis (TB) is one of the world's three major diseases, along with AIDS and malaria. In the case of S. Korea, about 20,000 new cases were reported every year, and the number of TB deaths is an average of 1,900 per year. Especially, the incidence rate and death rate of TB has ranked as the highest among OECD. This is because there are people with latent TB, which is estimated to be 30% of the total population. TB is a highly infectious disease because it is carried through tiny droplets during the breathing process of TB patients and spread to nearby people. After being infected with TB bacteria (Mycobacterium tuberculosis), about 90% remain in the dormant state (latent TB). As fatal active TB can be developed in case the immunity is lowered, preemptive treatment and response for latent TB are essential to prevent transmission.

As a method of diagnosing TB bacterial infection, the Interferon Gamma Releasing Assay (IGRA) has been introduced and used worldwide. IGRA is a method for confirming TB bacterial infection by measuring Interferon-gamma (IFN-r) secreted by immune T-cells that specifically respond to TB bacterial antigens.

The ‘ichroma™ IGRA-TB’ product was developed by combining a cell-mediated immune (CMI) response specific to M. tuberculosis and a lateral flow assay system. By using the ichroma™ reader to which Boditech Med's proprietary ultra-sensitive diagnostic technology is applied, it is possible to diagnose latent TB quickly and inexpensively within 15 minutes.

A company official said, "The existing ELISA (enzyme-linked immunosorbent assay) method required an expensive exclusive analyzer and experienced technician, so there were difficulties in early detection and management as well as an economic burden. Boditech Med's latent TB diagnostic kit, which will be supplied to the domestic market, is expected to greatly contribute to reducing the incidence and mortality of TB in Korea with faster results, accurate and reliable clinical performances, and improved ease of use for laboratories without expertise.