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Point-of-Care Coronavirus Test From Credo Diagnostics Biomedical Gets CE Mark

NEW YORK – Credo Diagnostics Biomedical announced on Tuesday it has obtained CE mark for an assay to detect SARS-CoV-2, the virus that causes coronavirus disease COVID-19. The test runs on the firm's point-of-care instrument and is now commercially available on countries accepting the CE designation.

The Credo platform, called VitaPCR, performs real-time PCR to detect pathogens in 20 minutes, with one minute of hands-on time. As previously reported, the system needs minimal training to run and involves no additional equipment.

Winston Wong, chairman of Singapore-based Credo, said that better tools are currently needed at front-line locations, like airports. "Rapid and accurate molecular screening [for the] COVID-19 strain will better help contain the virus and allow early actions to be taken, thus preventing tragedies," Wong said. 

The VitaPCR SARS-CoV-2 Assay is now also pending Emergency Use Authorization from the US Food and Drug Administration and Emergency Use Listing from the World Health Organization, the firm noted in a statement.