Biolidics To Commence Commercial Production Of Its ClearEpi SARS-COV-2 Neutralising Antibody Rapid Test Kit

Singapore, Dec 9, 2021 - (ACN Newswire) - Biolidics Limited ("Biolidics" or the "Company" and together with its subsidiaries, the "Group"), a medical technology company with a focus on innovative diagnostic solutions, is pleased to announce that it had on 8 December 2021: (i) entered into a definitive agreement with its contract manufacturer for the production of the ClearEpi NAB Test; and (ii) obtained the relevant product liability insurance for the ClearEpi NAB Test. The ClearEpi NAB Test was developed by Biolidics with technology licensed from A*STAR's A*ccelerate.

Highlights:
- Biolidics has entered into a definitive manufacturing agreement for the production of its ClearEpi SARS-CoV-2 Neutralising Antibody Rapid Test Kit (the "ClearEpi NAB Test") and obtained the relevant product liability insurance
- Unlike most commercially available COVID-19 serology tests which test for IgM/ IgG antibodies in patients, the ClearEpi NAB Test, developed by Biolidics with technology licensed from the Agency for Science, Technology and Research ("A*STAR")'s Accelerate Technologies Pte Ltd ("A*ccelerate"), provides results that may indicate an individual's protective immunity against COVID-19
- Neutralising antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection(1)
- The ClearEpi NAB Test can potentially serve as an important tool to assist in the area of assessing vaccine efficacy, vaccine deployment and social activities management (such as air travel(2)), among others
- The commercialisation of ClearEpi NAB Test is another Singapore medical technology innovation that showcases the strong collaborative partnerships between Singapore public agencies and the private sector
- The ClearEpi NAB Test has obtained the CE marking that allows it to be marketed and sold in the European Union

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 qualitative detection of neutralising antibodies in serum or plasma which provides an indication of the individual's protective immunity against COVID-19 infection(1),(3).

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 neutralising or "disarming" 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 via www.sgx.com.

About Biolidics Limited
(Bloomberg Code: BLD: Singapore / Reuters Code: BIOL.SI / SGX Code: 8YY)

Incorporated in 2009, Biolidics Limited is a precision medicine medical technology company with a focus in developing a portfolio of innovative diagnostic solutions to lower healthcare costs and improve clinical outcomes.

Biolidics has developed and commercialised the ClearCell FX1 System, a fully automated CE- IVD medical device which relies on a novel, patented technology to separate and enrich cancer cells from blood, allowing users of the system to perform liquid biopsies to test for the presence of cancer cells (specifically circulating tumour cells, or CTCs) in blood samples or perform further analysis on cancer cells.

Liquid biopsies (i.e. analysis of the CTCs in blood samples) have many applications throughout the various stages of a patient's cancer journey, from cancer screening and staging to personalised treatment, and post-cancer monitoring.

Biolidics also has a CAP accredited clinical laboratory in Singapore that offers a wide range of tests, which could potentially accelerate its revenue growth and execution of its business strategy in cancer diagnostics.

In addition, Biolidics has formed an infectious diseases division to develop certified test kits with various diagnostic partners.

Biolidics' quality assurance capabilities have been recognised through its ISO 13485 certification, CE-IVD, US FDA Class I registration and NMPA Class I registration.

© Scoop Media