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GenDx Biotech Secures Indonesian Import License for GENEYE® Mycobacterium tuberculosis (MTB) ERA Assay.

updated time:2025-04-25



Recently, GenDx Biotech self-developed rapid molecular diagnostic test assay for Mycobacterium tuberculosis, utilizing Tongue swab samples, was awarded an import medical device license by the Indonesian government. This milestone marks the recognition of GENEYE® ERA Technology by the Indonesian government.

 

As a Chinese company with the global exclusive patent for ERA technology, GenDx Biotech has pioneered a Easy, Rapid and Accurate nucleic acid detection solution. With the characteristics of delivering results in 10 minutes and being fully enclosed without the need to open the lid after sampling, it has gained favor in the Indonesian market and provided more comprehensive support for global tuberculosis prevention and control efforts.

 

According to the recommendations of the 2023 Global Tuberculosis Report, rapid molecular diagnostic technology, as the preferred method for initial tuberculosis screening, has high sensitivity and specificity, enabling early case detection, thereby improving diagnostic accuracy and shortening result turnaround time. However, the world still lacks mature and affordable rapid molecular diagnostic tools suitable for active tuberculosis screening, especially in resource-limited primary healthcare institutions and high-burden areas. The lack of decentralized diagnostic tools has posed a major obstacle to progress in tuberculosis control.

 

To address this challenge, GenDx Biotech has launched a rapid molecular diagnostic reagent for tuberculosis using nasal swab testing. The MTB nucleic acid detection kit combines high performance, low cost, speed, and convenience, making it an ideal choice for home testing and highly effective in resource-limited primary medical institutions.


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