Visby Medical's single-use, palm-sized Personal PCR platform is expected to provide a sample-to-result in less than 30 minutes. On September 16, 2020, Visby Medical received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Personal PCR device for use in moderate complexity CLIA certified laboratory settings. While currently only authorized for use in moderate complexity labs, the device is designed to one day benefit both point-of-care (POC) and over-the-counter (OTC) use cases, thus avoiding lengthy delays caused by sample transport, lab analysis, and result reporting. The device is designed to enable rapid, geographically distributed testing with accuracy equal to lab PCR instruments, meeting a critical, and as yet missing, need for testing in the U.S.
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