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Automated POCT for Pyrazinamide Drug Susceptibility Testing

Award type :
Product Development Award
Product type :
Diagnostics
Award year :
2021
Project start date :
09 / 27 / 2021
Project end date :
03 / 31 / 2023
Project duration (months) :
12
Development stage :
Early Validation
Target disease :
Tuberculosis
Region served :
World, Republic of Korea
Recipient organization / Country of funding recipient organization :
Bioneer / Republic of Korea
Collaborator(s) / Country :
International Tuberculosis Research Center (ITRC) / Republic of Korea
Funding amount(KRW) :
499,045,000

The pyrazinamide (PZA) drug resistance testing recommended by WHO for tuberculosis treatment is seldom conducted due to stringent laboratory requirements, which makes it unreliable in most settings. The team has developed an automated test on its diagnostic system to detect mutation in the gene, thereby significantly reducing the time to result from three weeks to nine hours. This approach is expected to measure PZA enzymatic activity from sputum or cell culture, with the potential of a significant impact on Tuberculosis treatment. Furthermore, the technology’s wider application in measuring enzymatic activity holds promise for addressing similar needs in various fields. The prototype of the Pyrazinamide-resistant Mycobacterium tuberculosis Detection kit showed more than 90% sensitivity, which makes it comparable to conventional methods.