Visby Medical announced that its instrument-free Reverse Transcription (RT)-Polymerase Chain Reaction (PCR) COVID-19 test was granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for testing pooled patient samples in high-complexity Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories.

This authorization extends the previous EUA for single patient sample testing at the point of care. 

According to the US Centre for Disease Control and Prevention (CDC), more than 32 million COVID-19 tests have been performed in the US alone over the past month. Pooling patient samples with the Visby test can help increase overall lab testing capacity without additional tools or resources while maintaining both accuracy and speed by returning results in less than 30 minutes.

The company's Covid-19 test pooling protocol enables high-complexity clinical laboratories to combine up to five patient samples into a single device for processing. A negative result means that all five individuals have tested negative for SARS-CoV-2. A positive result triggers all five samples to be re-tested individually to determine which patient or patients are infected.

By shrinking PCR technology to palm-sized dimensions, the Visby Medical platform provides fast, accurate results. This single-use, instrument-free device quickly identifies Covid-19 infections, which is especially useful in communities with limited access to testing.