PharmaCyte’s Licensed SARS-CoV-2 Tests Earn CE Mark

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.