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NGeneBio Gets CE Mark for NGS-Based Tuberculosis Assay

NEW YORK – NGeneBio, a precision diagnostics firm based in South Korea, has received the CE mark for a next-generation sequencing-based assay for tuberculosis, the firm announced on Monday.

The assay, called MTBaccuPanel, is a quantitative NGS assay for Mycobacterium tuberculosis and nontuberculous mycobacteria that also reports drug susceptibility.

Specifically, it uses targeted deep-sequencing of 29 MTB complex genes associated with drug resistance to isoniazid, rifampicin, and fluoroquinolone. The test can identify 180 types of nontuberculous mycobacteria and 16 types of drugs resistance with a single test, NGeneBio said in a statement, adding it is also the first CE-IVD-marked NGS panel for TB diagnosis in Asia.

NGeneBio debuted in 2017 with a CE-marked NGS test to detect mutations in BRCA1 and BRCA2 genes that are associated with a predisposition to developing breast and ovarian cancers.

The firm has also developed NGS panels for solid tumors and hematological cancers, human leukocyte antigen typing, and a comprehensive genomic profiling panel that detects more than 300 genes related to 35 types of cancers, provides information on targeted therapy, and can detect microsatellite instability and tumor mutation burden.