The commercial production for the ClearEpi NAB Test by the Company is expected to commence in the current financial year ending 31 December 2021.
The clinical validation of the ClearEpi NAB Test was undertaken in Singapore. Biolidics engaged A*STAR Infectious Disease Labs (ID Labs) for the screening of the prototype, as part of the clinical validation of the ClearEpi NAB Test conducted by Biolidics. ID Labs is an A*STAR research institute set up in April 2021 to undertake disease-specific research efforts within A*STAR.
On 20 September 2021, the Group announced that it has developed the ClearEpi NAB Test that is intended for the qualitative detection of neutralising antibodies in serum or plasma which provides an indication of the individual’s protective immunity against COVID-19 infection.
Most commercially available serology tests against COVID-19, including the Company’s COVID-19 Antibody Test Kit launched on 30 March 2020, test for the presence of IgM/IgG antibodies. The presence of IgM/IgG antibodies indicates whether an individual has been previously infected. Not all antibodies have to neutralise or “disarm” capacity.
Neutralising antibodies, on the other hand, bind to regions of the virus that “disarm” or prevent infection directly. The presence of neutralising antibodies provides indications that an individual has protective immunity against infection1,3. Nonetheless, it is important to note that information is still emerging from researches in relation to the level of antibodies sufficient to confer protective immunity to an individual, and how long such protective immunity against COVID-19 may last in an individual.
In addition, the Group announced on 20 September 2021 that it had received confirmation for the CE marking for the ClearEpi NAB Test which enables the Company to market and sell the ClearEpi NAB Test in the European Union.
Mr Song Tang Yih, Executive Director and Chief Executive Officer of Biolidics, said, “As the COVID-19 pandemic becomes endemic, we believe that our ClearEpi NAB Test can
become a vital tool in assessing vaccine candidates and formulate vaccine deployment strategies (such as the need for additional booster doses). With our ClearEpi NAB Test, the testing of neutralising antibodies may also serve as a guide for government agencies to accelerate the re-opening of the economy, social activities and global travel.”
This document is to be read in conjunction with Biolidics’ exchange filings on 8 December 2021, which can be downloaded here.