Singapore-listed medtech company Biolidics announced that it has completed the notification process for the intended distribution of its rapid test kits for COVID-19 under Section IV.D of the “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency” (Policy D) of the United States of America (USA) and it has received an acknowledgement from the U.S. Food and Drug Administration (FDA) on April 9 2020.
Under Policy D, which applies to developers of serology tests that identify antibodies (e.g., IgM, IgG) to SARS-CoV-2 (the virus that causes COVID-19) from clinical specimens, Biolidics’ COVID-19 rapid test kits are only for use by clinical laboratories or healthcare workers for point-of-care testing and not for at home testing.
The medtech 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 has also emphasized that its COVID-19 rapid test kits have not been granted an Emergency Use Authorization by the FDA and that it is required to complete the listing of its COVID-19 rapid test kits before they can be distributed, marketed and sold to clinical laboratories and healthcare workers for point-of-care testing.
THE LARGER TREND
Late last month, Biolidics officially launched its COVID-19 rapid test kits, and it has entered into a manufacturer agreement with a diagnostic kit manufacturer to customize and manufacture the rapid test kits, MobiHealthNews reported.
The medtech company also recently obtained CE Marking for its COVID-19 rapid test kits, a notification process to the relevant authority that enables Biolidics to market and sell its rapid test kit in the European Union (EU). The kit has also been approved for use by the FDA in the Philippines.
In the US, Cellex became the first company to gain an FDA Emergency Use Authorization for a serology test. The test was designed to identify specific antibodies in the blood linked to coronavirus, which means it can be used to identify past coronavirus infections. Currently, the authorization is limited to specific laboratories. The test is not meant to be used to determine whether or not a person is positive for the virus.