SINGAPORE (THE BUSINESS TIMES) – Biolidics on Monday (Sept 21) said it has developed a new product which detects an individual’s protective immunity against Covid-19.
The medtech company has also obtained confirmation for the CE marking of its ClearEpi NAB Test product. This allows it to market and sell the test in the European Union (EU), as it complies with the relevant EU safety, health and environmental protection requirements.
That being said, the CE marking does not guarantee that the company will be able to secure supply or successfully commercialise the ClearEpi NAB Test.
On this note, Biolidics said it is in the process of negotiating a definitive agreement with its contract manufacturer for the product and getting the relevant product liability insurance. The test is not intended for at-home testing and will be limited to professional use.
Biolidics shares jumped when the stock market opened on Tuesday after the announcement. The counter was trading at 14.1 cents, up 1.3 cents or 10.2 per cent, at 9.11am.
The ClearEpi NAB Test incorporates the technology used to detect Covid-19 viral spike proteins. Viral spike proteins bind to the surface of an individual’s cells, including lung cells, in the process allowing Covid-19 to enter the cells and result in an infection.
Biolidics said the ClearEpi NAB Test is intended for the qualitative detection of circulating human IgG neutralising antibodies capable of attaching to the Covid-19 spike proteins and preventing binding.
“The company wishes to highlight that the ClearEpi NAB Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2 and should not be used to diagnose or exclude acute SARS-CoV-2 infection,” Biolidics added.
Biolidics expects the development of the test and the receipt of the CE marking to contribute positively to its revenue for the financial year ending Dec 31, 2021, provided the company is able to successfully market and commercialise the test in the EU.
It is unable to quantify such financial impact as the test has not yet been launched, hence sales uptake cannot be determined.