Biopromic, in collaboration with Asahi-Kasei Corp. has been awarded a GHIT grant for development of LFA platform for improving sensitivity of Point-of-Care assays for infectious disease with main focus on Tuberculosis and Malaria.

Despite intense efforts to eliminate malaria, tuberculosis and a number of other infectious diseases only moderate to low success has been achieved. Thus, highlighting the necessity to expand and refine current eradication strategies, in particular those targeting the early detection in endemic areas.

Point-of-care (POC) tests dramatically enhanced physician’s ability to diagnose patients’ diseases rapidly and accurately at a bed side or even by the patient himself. Nevertheless, currently there is only a small number of infections POC tests available and they represent a fraction of the actual demand for this kind of diagnostics (WHO TPP for infectious disease diagnostics).
The greatest challenge in POC diagnostics is the very low concentration of antigens in the sample which are easily accessible. Current LFA devices offer analytical sensitivity above 1-5ng/ml.
Taking into account that in case of tuberculosis and malaria patients’ concentration of antigens in the samples is usually below 100pg/ml there is a clear need for more sensitive LFA systems to be developed.
Biopromic and Asahi Kasei aim to develop a new Lateral Flow Assay (LFA) platform aiming at up to 50x improvement of antigen detection from current industry standard.  
Ability of testing for TB and Malaria outside of the centralized laboratory system without the need for high-end equipment is the ultimate goal in the development of infectious disease diagnostics.
“To our knowledge, our platform would be  able to uniquely improve the sensitivity of the tests without the need for read-out equipment, allowing for true bed-side diagnostics.”
Early detection of active cases in case of TB and asymptomatic malaria patients is the key to disease eradication. Currently TB patients are infectious months before the diagnosis with sputum sample can be achieved.
In case of malaria it has been described that during periods of limited to no transmission, e.g. the dry season, P. falciparum commonly resides inside its human host in very low numbers and this small minority of malaria infected individuals is sufficient to maintain or re-initiate malaria transmission. Therefore sensitive low cos PoC is a global health must. We aim to move the infectious disease diagnostics from the centralized lab setting closer to the patient. Ideally, allowing first contact medical staff to perform the tests immediately on site.
 
In a nutshell:
  • Project: Development of LFA platform for improving sensitivity of Point-of-Care assays for infectious disease with main focus on Tuberculosis and Malaria.
  • Awarded Amount: $1,000,000
  • Disease: Tuberculosis and Malaria
  • Intervention: Diagnostic, Concept Stage
  • Collaboration Partners: Biopromic AB, Asahi Kasei Corporation
  • Awarding body: Global Health Innovative Technology Fund, Japan.

More info at: https://www.ghitfund.org/investment/portfoliodetail/detail/140