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
Share on facebook
Share on twitter
Share on linkedin
Share on pinterest
Share on whatsapp
Share on email
Share on facebook
Share on twitter
Share on linkedin
Share on google
Share on whatsapp
Share on email

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:


Helping Your Lab Stay Afloat During Challenging Times

Dear Colleague,

Robert L. MichelIn these challenging times for our colleagues in clinical laboratories, pathology practices and hospital administration, The Dark Intelligence Group (TDIG) — through generous grants from our partners — is bringing you the COVID-19 STAT Intelligence Briefings.

We’ve added analysts, writers and skilled editors to the COVID-19 STAT team to uncover, analyze, and immediately report to you what’s happening with the SARS-CoV-2 pandemic, packaged with the insights you need to deliver quality testing for patient care and keep your lab’s financial ship afloat. As part of our mission, we are also bringing you real-time data from our partners around testing that you will not find anywhere else.

Please let me know how we can better improve this service to fit your needs. If you would like to offer a grant to keep our mission going with this site, please contact me at


Robert L. Michel
President, Founder
The Dark Intelligence Group