Biolidics gets confirmation to market, sell Covid-19 antigen test kit in the EU

SINGAPORE (THE BUSINESS TIMES) - Medtech firm Biolidics on Monday (Jan 25) launched a Covid-19 antigen test kit which can be marketed and sold in the European Union (EU).

The raw materials of the antigen test kit, named ClearEpi Sars-CoV-2 Antigen Rapid Test Kit (ClearEpi ART), are sourced from JOYSBIO (Tianjin) Biotechnology Co, which Biolidics has a distribution agreement with. The kits are packaged and labelled by third-party manufacturers.

The antigen test kit on Monday received confirmation for its CE marking, a notification process which indicates that the ClearEpi ART complies with relevant EU safety, health and environmental protection requirements.

Antigen test kits - administered via nasal swabbing from the lower part of the nose - seek to detect viral proteins in patients during the acute phase of Covid-19.

They are different from serology tests, which draw blood and detect antibodies, and have lower sensitivity and specificity than polymerase chain reaction tests. For this reason, Biolidics said ClearEpi ART results are only for clinical reference and should not be the only basis for clinical diagnosis and treatment.

Biolidics expects the launch of ClearEpi ART and/or the CE marketing to contribute positively to the group's revenue for the financial year ending Dec 31, 2021. This is barring unforeseen circumstances and given the ongoing Covid-19 pandemic.

Shares of Catalist-listed Biolidics were trading 7.9 per cent or 2.5 cents higher at 34 cents as at 9.17am on Tuesday, after the announcement.

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