Biolidics to distribute Covid-19 test kits in the US
Singapore-based cancer diagnostics company Biolidics said yesterday it has notified and received acknowledgement from the US Food and Drug Administration (FDA) of the intended distribution of its Covid-19 rapid test kits in the United States.
The Catalist-listed company’s kits will be allowed for use by clinical laboratories or healthcare workers for point-of-care testing, but not for home testing.
Biolidics noted that the test kits have not received emergency-use authorisation by the FDA. It has to complete the listing of the Covid-19 kits before they can be distributed, marketed and sold. It said it is in the process of completing the listing.
For the US, the company will be required to state in its test reports that the tests have not been reviewed by the FDA and that negative results do not rule out the novel coronavirus infection.
Biolidics recently obtained approval to sell its test kits in the European Union and the Philippines.
In Singapore, the company disclosed the approval received for the kits only after it was certain they could be commercialised, Biolidics said last Thursday in response to the Singapore Exchange’s queries. The bourse operator had asked why the firm disclosed this at least a week after the Health Sciences Authority had already announced the information.