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May 20, 2022
Health Law Weekly

FDA Authorizes First Non-Prescription COVID Test for Multiple Respiratory Viruses

  • May 20, 2022

The Food and Drug Administration (FDA) authorized May 16 the first COVID-19 test that will be available without a prescription that also screens for influenza and respiratory syncytial virus, commonly known as RSV.

The Labcorp Seasonal Respiratory Virus RT-PCR home collection kit can be purchased online or in a store without a prescription, allowing individuals to self-collect a nasal swab sample at home and send it to Labcorp for testing. Results will be made available through an online portal, the FDA said.

“The rapid advances being made in consumer access to diagnostic tests, including the ability to collect your sample at home for flu and RSV without a prescription, brings us one step closer to tests for these viruses that could be performed entirely at home,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.

 

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