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September 14, 2021

Visby Medical’s Covid-19 RT-PCR test obtains FDA EUA

The pooling protocol allows high-complexity labs to combine and process up to five samples into a single device. 

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Visby Medical’s instrument-free reverse transcription (RT)-polymerase chain reaction (PCR) Covid-19 test for pooled samples.

The single-use, instrument-free device is intended for use in assessing pooled patient samples in Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories.

Visby noted that the Covid-19 test pooling protocol allows high-complexity labs to merge up to five patient samples into a single device for processing.

A negative result indicates that all five people have tested negative for Covid-19, while obtaining a positive result requires further individual testing of all five samples.

By reducing PCR technology to palm-sized dimensions, the Visby Medical platform offers quick and precise results.

The latest EUA expands the previous authorisation for single patient sample testing at the point of care setting.

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

Visby Medical Affairs director Teresa Abraham said: “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.

“Thanks to this EUA, laboratories can meet increasing testing demand by analysing up to five patient samples at once, allowing for significantly increased efficiency and significantly decreased testing costs, particularly in low prevalence settings.”

In February, the US Biomedical Advanced Research and Development Authority (BARDA) awarded $12.3m to Visby Medical to accelerate the development of its rapid, single-use Flu-COVID PCR Test.

In a separate development, the FDA has expanded the EUA label for Quanterix’s Simoa SARS-CoV-2 N Protein Antigen Test to incorporate testing with a nasal swab and saliva samples along with asymptomatic serial testing with nasal swab samples.

The test runs on the company’s fully automated high-throughput immunoassay instrument, Simoa HD-X Analyzer.

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