Biolidics gets confirmation to market, sell Covid-19 antigen test kit in the EU
Add BT as a preferred source
DeeperDive is a beta AI feature. Refer to full articles for the facts.
MEDTECH firm Biolidics on Monday 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.
Navigate Asia in
a new global order
Get the insights delivered to your inbox.
Shares of Catalist-listed Biolidics were trading 7.9 per cent or 2.5 Singapore cents higher at 34 cents as at 9.17am on Tuesday.
Decoding Asia newsletter: your guide to navigating Asia in a new global order. Sign up here to get Decoding Asia newsletter. Delivered to your inbox. Free.
Copyright SPH Media. All rights reserved.
