BIOLIDICS LIMITED
(Company Registration Number: 200913076M)
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NOTIFICATION TO THE U.S. FOOD AND DRUG ADMINISTRATION FOR THE INTENDED
DISTRIBUTION OF BIOLIDICS’ RAPID TEST KITS FOR NOVEL CORONAVIRUS 2019
The board of directors (the "Board") of Biolidics Limited (the "Company") is pleased to announce that
the Company has completed the notification process for the intended distribution of its rapid test kits for
Novel Coronavirus 2019 (the "COVID-19 Rapid Test Kits") 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”), a federal agency of the United States Department of Health and Human
Services, on the notification process on 9 April 2020 (Singapore time).
Under Policy D, which applies to developers of serology tests that identify antibodies (e.g., IgM, IgG) to
SARS-CoV-2 (the virus which causes the disease, the Novel Coronavirus 2019) from clinical specimens,
the Company’s 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 Company is also required to provide information
along the lines of the following in the test reports:
- The test has not been reviewed by the FDA;
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in
contact with the virus. Follow-up testing with a molecular diagnostic should be considered to
rule out infection in these individuals;
- Results from antibody testing should not be used as the sole basis to diagnose or exclude
SARS-CoV-2 infection or to inform infection status; and
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus
strains, such as coronavirus HKU1, NL63, OC43, or 229E.
The Company wish to highlight that its COVID-19 Rapid Test Kits have not been granted an Emergency
Use Authorization by the FDA and the Company 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 “Listing”). The Company is currently in the process of completing
the Listing.
More details about Policy D can be found here:
www.fda.gov/media/135659/download
The Company will make the appropriate announcement(s) as and when there is further material
development relating to this matter.
BY ORDER OF THE BOARD
