NGeneBio said Wednesday that the company has registered a domestic patent for its tuberculosis (TB) diagnostic technology based on next-generation sequencing (NGS) technology.

The patent is the “Composition for gene amplification for detecting mycobacterium tuberculosis and determining drug resistance and its use.”

The patent applies to MTBaccuPanel, a TB diagnostic product that has obtained the European In Vitro Diagnostic Device (CE-IVD) certification, which uses NGS technology to test 27 types of TB bacteria, non-TB bacterial infections, and drug resistance gene mutations at once. As little as one ng (nanogram) of M. tuberculosis DNA is required for diagnosis, and results are available within two days of testing, according to the company.

The existing TB diagnostic test method first distinguishes between M. tuberculosis and non-M. tuberculosis antibacterial bacteria through the Identification of MTB test, and then confirms drug resistance using molecular diagnostics and M. tuberculosis culture. The molecular diagnostic method is a rapid test. Still, it can only detect resistance genes to the first-line TB drugs Rifampin/Rifampicin and Isoniazid, and it is impossible to diagnose resistance to second-line drugs.

On the other hand, the TB culture test method is highly accurate, but it takes three to eight weeks to culture TB bacteria, which can delay treatment or worsen the disease.

"By utilizing NGS technology to simultaneously detect 180 non-TB antioxidant bacteria and 16 TB drug resistance variants in a single test, we can shorten the test time to up to two days," NGeneBio said. "With conventional methods, it took two months to test. However, this rapid and accurate diagnosis enables early and effective treatment, especially for multidrug-resistant and extensively drug-resistant TB."