This article has been updated to correct that Hai Kang Life, not PharmaCyte Biotech, received the CE mark for these tests.
NEW YORK – PharmaCyte Biotech announced on Wednesday that Haig Kang Life has received the CE mark for SARS-CoV-2 tests it has licensed from Hai Kang.
The CE mark was given to RT-PCR and enhanced fluorescence RT-PCR tests, which can now be marketed as in vitro diagnostics in the EU to detect the coronavirus.
In a statement, PharmaCyte CEO Kenneth Waggoner said that the firm is working with Hai Kang to update its submission to the US Food and Drug Administration for Emergency Use Authorization with the agency’s pool testing protocol.
Based in Laguna Hills, California, PharmaCyte develops cellular therapies for cancer and diabetes. Its flagship technology is a cellulose-based live cell encapsulation method called Cell-in-a-Box.
Hai Kang is a molecular diagnostics company based in Hong Kong.