University of Chile License to C-TAP

In July 2023, under the auspices of WHO’s COVID-19 Technology Access Pool (C-TAP), the Medicines Patent Pool signed a worldwide license with Universidad de Chile for a system for quantification of neutralizing antibodies (NAbs) against SARS-CoV-2. This diagnostic can be used in facilities using heightened control measures similar to Biosafety Level 2 (BSL-2) laboratories.

Technology offered: System for quantification of neutralizing antibodies (NAbs) against SARS-CoV-2.

Technology holder: Universidad de Chile

License: Worldwide, non-exclusive and transparent license available here

C-TAP categorization after WHO technical pre-assessment: Category II

Description of the technology: The technology is designed as a system for quantification of neutralizing antibodies (NAbs) against SARS-CoV-2 that can be used in facilities using heightened control measures similar to Biosafety Level 2 (BSL-2) laboratories. Detecting presence of neutralising antibodies is considered important as these antibodies are known to inactivate virus particles so they are no longer infectious or pathogenic. Hence, a neutralizing antibody test has three main uses: 1. To monitor or detect previous COVID-19 infection; 2. To confirm if someone has produced an immune response after being infected; 3. To monitor antibody response.  

The aim of this license is to facilitate rapid manufacture and access to the licensed technology worldwide. The agreement covers transfer of all know-how, protocols and biological materials needed to manufacture the diagnostic test. This represents the first transparent, global, non-exclusive license for a COVID-19 health tool received from an academic institution and included in the WHO COVID-19 Technology Access Pool.  

The technical assessment from WHO concluded that the technology’s significant advantage is that it can be utilized in places with heightened control measures similar to Biosafety Level 2 (BSL-2) laboratories, capabilities and where access to containment laboratory with inward directional airflow (heightened control measures/BSL-3) facility is unavailable. 

The prototype was used for performance of a small size clinical validation, and the results indicated compliance of the manufacturer’s qualitative assay with WHO requirements. The quantitative aspects of the assay may require a larger sample size to either confirm the evaluators’ finding or to provide more evidence that the assay is suitable as a quantitative assay (based on comparison to a comparator neutralization assay). 

C-TAP invites interested manufacturers based anywhere in the world to express their interest in obtaining a sublicence by submitting a single email to CTAPDiagnostics@medicinespatentpool.org.