First Instrument-Free COVID-19 RT-PCR Test Granted FDA EUA for Pooled Samples

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. Furthermore, this validates the flexibility and adaptability of the Visby Medical innovative, palm-sized PCR technology by expanding its proven capabilities from individual, single-use testing to pooled testing of up to five patient samples at once. 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 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.

"With the SARS-CoV-2 virus ravaging the country, Visby remains steadfast in meeting the urgent needs of the community, its partners, and the changing market dynamics with our instrument-free PCR COVID-19 test," said Teresa Abraham, PhD, Director, Medical Affairs at Visby Medical. "Thanks to this EUA, laboratories can meet increasing testing demand by analyzing up to five patient samples at once, allowing for significantly increased efficiency and significantly decreased testing costs, particularly in low prevalence settings."

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