Investment

Details

Development of LFA platform for improving sensitivity of Point-of-Care assays for infectious disease with main focus on Tuberculosis and Malaria.
  • RFP Year
    2018
  • Awarded Amount
    $1,000,000
  • Disease
    Tuberculosis
  • Intervention
    Diagnostic
  • Development Stage
    Concept Development
  • Collaboration Partners
    Asahi Kasei Corporation, Biopromic AB

Introduction and Background of the Project

Introduction

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.

 

Project objective

In this project, we plan to develop a new Lateral Flow Assay (LFA) platform aiming at up to 50x improvement of antigen detection from current industry standard.  

 

Project design

Achieving such a high analytical sensitivity of the LFA tests requires significant improvement and integration of multiple components of the LFA system. .

To achieve this goal we will combine, integrate and optimize over 5 technologies which were developed by the project partners, in 3 phases of the project.

  1. Cross-partner technology testing and detailed TPP development where we develop a  detailed TPP for the platform. While TPP for each of the technologies exist (or the products are already implemented on the market) a product combining multiple of them would require a separate, balanced approach.
  2. Technical feasibility testing of combined technologies and their modifications to work within the platform where at the end of this phase we expect all the potential modifications to be complete and a platform to be ready for the prototype phase.
  3. Development of a LFA prototype test and its initial testing

In this final stage of the project we aim to build two prototypes of POC-LFA tests which utilize the solutions from phase 2 and validate the designs on laboratory and patient

How can your partnership (project) address global health challenges?

Aside from effective vaccines a major global health need is a fast, cheap and sensitive DIY-type diagnostics for TB and malaria.

The inability to diagnose or monitor numerous diseases rapidly is a major cause of prolonged sickness or death regardless of the economic status of a country or the patient. 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 uniquely able to 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.

As our long-term goal is to establish a platform allowing for other diseases to be diagnosed in the same manner as the global health impact of this project, in our opinion, will be significant. 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.

What sort of innovation are you bringing in your project?

There are multipole novel technologies which both partners will utilize in this project

  • NanoAct Cellulose beads - Highly colored cellulose nano beads for LFIA labels enable to obtain improved sensitivity, stability and reproducibility over existing colored labels such as colloidal gold and colored latex.
  • Nonwoven Pads – new nonwoven pads made of continuous nonwoven and significantly reduce lint comparing to many short fiber materials and increase the flow rate or the amount of liquid adsorption.
  • New proprietary conjugation technology able to specifically immobilize mAbs to uniquely coated nanoparticles possessing different surface chemistries. Resulting mAb-particle conjugates are stable and superior in terms of antigen binding efficiency.
  • Signal intensification– a technology allowing for significant visual readout increase of the signaling particles on the Lateral Flow membrane

Role and Responsibility of Each Partner

Due to the fact that both Asahi-Kasei and Biopromic bring in sets of their respective technologies into the platform, both parties will be responsible equally for the technical development with each taking a lead in the modification of its respective technologies.

Asahi Kasei will be primarily responsible for the membrane and pad materials as well as for the NanoAct particles and Biopromic is taking charge of conjugation and signal enhancement. Additionally, Asahi-Kasei will be responsible for LFA builds and optimization while Biopromic will develop and provide necessary antibodies.

Project management will be handled by a steering committee consisting of two representatives from each party.