Research & Development
PharmaCyte Biotech gets EU approval for licensed COVID-19 molecular tests
30 July 2020 -

Biotechnology company PharmaCyte Biotech Inc (OTCQB:PMCB) said on Wednesday that the COVID-19 molecular tests licensed from Hai Kang Life Corporation Limited have received the CE mark, allowing the tests to be marketed in the European Union.

The Declaration of Conformity confirms that the RT-PCR and ERT-PCR tests meet the requirements of the EU's In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC), permitting export and sales of the tests in European Union member countries.

PharmaCyte Biotech is also working with Hai Kang to update its Emergency Use Authorization (EUA) submission with the Pool Testing Protocol released by the US Food and Drug Administration (FDA) in early June.

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