- RFP Year2020
- Awarded Amount$2,266,257
- Development StageProduct Validation
- Collaboration PartnersAsahi Kasei Corporation, Biopromic AB
- Past Project
Introduction and Background of the Project
Tuberculosis (TB) remains one of the leading infectious diseases in the world, having caused 1.4 million deaths (including 208 000 with HIV) in 2019. In the absence of a simple, cost effective and reliable rapid diagnostic test (RDT) around 30% of the annual 10 million new TB cases remained undiagnosed. This is primarily due to the lack of a non-sputum based rapid diagnostic test for the detection of TB biomarker in the biological sample like urine.
The rapid diagnostic test co-developed by Asahi Kasei Corporation (Japan) and Biopromic (Sweden) detects picogram amount of Lipoarabinomannan (LAM) TB biomarker in the urine of TB patients irrespective of HIV infection in timely manner with high accuracy.
The main objective is to validate a Rapid Diagnostic Test which is currently developed by Asahi Kasei and Biopromic for diagnosis of tuberculosis in TB patients irrespective of HIV status. Moreover, the test should meet the WHO TPP criteria.
Asahi Kasei´s and Biopromic´s RDT test will be evaluated by analysis of more than 1000 well-characterized clinical samples collected from South Africa and Uganda to determine the accuracy of the test.
How can your partnership (project) address global health challenges?
The inability to diagnose tuberculosis rapidly is a major cause of prolonged sickness and death. Early detection of TB cases and treatment is the key to stop TB spreading.
The Asahi Kasei´s and Biopromic´s test will provide affordable, simple and accurate diagnostic tests that allows the medical staff to perform the test on site without the need of centralized lab seething.
What sort of innovation are you bringing in your project?
The only available non-sputum test in the market has not enough sensitivity to be used as a reliable test for diagnosis of TB patients especially in the TB population without HIV infection. The Asahi Kasei´s and Biopromic´s RDT test will apply a novel proprietary technology regarding sample preparation and labeling particles that allows LAM TB biomarker detection at lower picogram level, which is 100 times higher than the only test available so far.
Role and Responsibility of Each Partner
Biopromic will be responsible for the production of specific monoclonal antibodies, purified biomarker and reagents for the enrichment of the LAM biomarker at large scale that requires for generation of a substantial numbers of RDT test to perform the evaluation studies. Biopromic will also be responsible for the collection of the clinical samples in coordination with the sites in Africa. Asahi Kasei will be responsible for generation and optimization of the RDT test.