Genematrix’s new product was granted a manufacturing license by the Food and Drug Safety Administration

[이데일리 최훈길 기자] GeneMatrix (109820) announced on the 28th that its new tuberculosis/non-tuberculosis mycobacteria diagnostic ‘Neoplex (TB/NTM Detection Kit)’ has received manufacturing approval for in vitro diagnostic medical devices from the Ministry of Food and Drug Safety.

‘Neoplex’ is a PCR-based molecular diagnostic product that immediately differentiates between Mycobacterium tuberculosis and non-Mycobacterium tuberculosis. Unlike conventional tests that use cultured fluid as a sample, human sputum can be used to rapidly test for Mycobacterium tuberculosis and highly pathogenic non-tuberculous mycobacteria.

Korea has the highest incidence of tuberculosis among member countries of the Organization for Economic Co-operation and Development (OECD). Since joining the OECD in 1996, it has been ranked first in the incidence rate every year. Although the annual number of tuberculosis cases is falling through the national tuberculosis prevention project, more than 10,000 new cases of tuberculosis occur each year. In 2020, tuberculosis is still a disease with a high social burden, recording the highest number of deaths among legitimate infectious diseases in Korea.

Non-tuberculous mycobacteria (NTM) are identified as the causative bacteria for more than 90% of cases of lung disease. The incidence rate is gradually increasing, including in Korea. Nontuberculous mycobacterial lung diseases are not easily distinguished from pre-existing lung diseases such as tuberculosis and chronic obstructive pulmonary disease. As tuberculosis and other antibiotic prescriptions are required, a rapid and accurate differential diagnosis is required. ‘Neoplex’ is capable of rapid differential diagnosis of tuberculosis and non-tuberculous mycobacteria.

An official from GeneMatrix said, “The acquisition of the Food and Drug Administration’s manufacturing license is a follow-up to the acquisition of the European medical device certification (CE-IVD) in August last year.” a generation multiplex product that can be quantitatively and rapidly examined. We look forward to it as a next-generation item that will lead the Non-COVID 19 diagnostic product business.”

Kim Soo-ok, CEO of GeneMatrix, said, “We plan to continuously launch differentiated new products that meet clinical demand in the post-coronavirus era.” We will accelerate the expansion of the global molecular diagnostics market by strengthening our non-corona product portfolio.”