www.fdanews.com/articles/198299-pharmacytes-licensed-sars-cov-2-tests-earn-ce-mark
PharmaCyte’s Licensed SARS-CoV-2 Tests Earn CE Mark
July 31, 2020
PharmaCyte Biotech has earned a CE Mark certification for two COVID-19 polymerase chain reaction (PCR) tests and is launching them in Europe.
The Laguna Hills, California company licensed the two tests — a reverse transcription PCR test and an enhanced fluorescence real-time reverse transcription PCR test — from the Chinese company Hai Kang Life.
PharmaCyte said it plans to seek FDA authorization for a pool testing protocol that would allow multiple samples to be analyzed together.