POCT for Multidrug-Resistant TB

Award type :
Product Development Award

Product type :
Diagnostics

Award year :
2019

Project start date :
09 / 18 / 2019

Project end date :
12 / 31 / 2023

Project duration (months) :
30 / 30

Development stage :
Late Validation, Clinical Validation

Target disease :
Tuberculosis

Region served :
Low- and Middle-Income Countries

Recipient organization / Country of funding recipient organization :
Bioneer / Republic of Korea

Collaborator(s) / Country :
Foundation for Innovative New Diagnostics (FIND) / Switzerland, International Tuberculosis Research Center (ITRC) / Republic of Korea

Funding amount(KRW) :
3,269,557,978

Only 25% of patients with drug-resistant tuberculosis (DR-TB) worldwide are diagnosed and given adequate treatment. In addition, the currently available diagnostic tests for DR-TB offer only rifampicin detection. Bioneer aims to develop and validate a multidrug-resistant TB diagnostic test kit ported on a point-of-care (POC) molecular diagnostic platform. This kit will enable the simultaneous detection of Mycobacterium TB resistant to rifampicin, fluoroquinolones, isoniazid, and aminoglycoside drugs. The analytical laboratory evaluation will be conducted by the International Tuberculosis Research Center (ITRC) and a multi-center clinical evaluation will be conducted by the Foundation for Innovative New Diagnostics (FIND) for the submission of the dossier for the World Health Organization review.