COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

COVID-19 Briefings

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

FDA Issues First EUA for At-Home, Non-Prescription Molecular COVID-19 Test

FDA maze of regulations

In a new first, molecular testing for COVID-19 can now be performed at home without a prescription, changing the COVID-19 testing market

The US Food and Drug Administration (FDA) issued a new emergency use authorization (EUA)—the first of its kind for a COVID-19 test that performs at-home molecular testing and can also be purchased without a prescription. This EUA was issued to Cue Health Inc. for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use.

While another COVID-19 antigen test had previously received an EUA for at-home OTC testing, the Cue test marks the first time these provisions have been made for a test that analyzes genetic materials.

The Cue COVID-19 Test for Home and Over The Counter (OTC) Use can be used with adult assistance for children as young as 2 years old and is designed to be collected as a nasal swab. The analyzer is wirelessly connected to a smartphone app, allowing for tracking of results for contact tracing purposes.

The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeffrey Shuren, MD, JD, Director of the FDAs Center for Devices and Radiological Health, in a statement. Cue COVID-19 Test for Home and Over-the-Counter (OTC) Use provides access to accurate and reliable testing at-home, without a prescription. The FDA will continue to work collaboratively with test developers to advance effective testing options for doctors, clinicians, and the public.”

Related Resources: