Biolidics' test kits no longer listed on US FDA website

This follows its withdrawal of application for emergency use authorization (EUA) on 30 June.

Biolidics Limited has announced that its COVID-19 antibody test kits are no longer listed in Section IV-D of the Policy for Coronavirus Disease-2019 Tests from the US Food and Drug Administration (US FDA) website.

This follows its application to the US FDA on 30 June to voluntarily withdraw its application for emergency use authorization (EUA) pursuant to the FDA Serology Test Policy. With its approval, the current COVID-19 antibody test kits will no longer be available in the US market.

Also read. Biolidics terminates US sale of COVID-19 test kits

Biolidics said it has made a full refund for all deposits paid by Aytu with respect to all undelivered orders of the COVID-19 antibody test kits in a statement responding to the Singapore Exchange's queries.

The company has delivered 13,000 test kits to Aytu. Under the terms of the termination agreement, Aytu will return these test kits to Biolidics and no refund is required.

Biolidics intends to distribute the COVID-19 Antibody Test Kits returned by Aytu to other markets outside of the US.

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