Genematrix said Monday that it obtained the Conformité Européene In-vitro diagnostic (CE-IVD) device certification for its new Neoflex TB/NTM-5 detection kit, a new respiratory diagnostic product.

The kit can identify one type of mycobacterium tuberculosis (TB) and five different types of non-tuberculous mycobacterium (NTM). Unlike conventional products that are tested for culture fluid, a total of six types of tuberculosis-related bacteria can be identified quickly and accurately using human sputum.

The World Health Organization (WHO) designated TB-related pulmonary disease as an infectious disease with more than 10 million patients worldwide annually.

It also has a very high public health risk, along with AIDS and malaria.

Recently, the prevalence of NTM lung disease has been gradually increasing, especially in Western society, and also in Korea. NTM lung disease is difficult to treat due to its high antibiotic resistance, and if there is no proper treatment, it can lead to death. Therefore, customized diagnosis and treatment for each strain is essential.

Additionally, the symptoms are similar to those of existing respiratory diseases such as TB, chronic obstructive pulmonary disease, and bronchodilator diseases. Moreover, early imaging diagnoses cannot easily distinguish the disease, so there has been a demand for a quick and convenient diagnosis method.

"The Neoflex TB/NTM-5 detection kit is an innovative product that enables accurate differentiation of TB and NTM lung diseases that are difficult to diagnose and treat,” said a company official, “It simultaneously can quantitatively determine the number of pathogens so that the therapeutic effect can be monitored."

The company said that they will continue to introduce new products to the market that meet the needs of the clinical field in order to enhance competitiveness in the diagnostic segment of respiratory pathogens, which are increasing in demand in the global diagnostic market.