Cue Is Taking the EUA Route for Rapid COVID-19/Flu Test

The measure comes a few months after the San Diego, CA-based company had to let go of 170 people because of a decline in demand for COVID-19 testing.

Omar Ford

October 4, 2022

2 Min Read
Image courtesy of caia image / Alamy Stock Photo

Cue Health is looking to bring a rapid test onto the market that will distinguish between COVID-19 and the flu.

The San Diego, CA-based company said Tuesday that it submitted an application with FDA for emergency use authorization for the Cue Flu+COVID-19 Molecular Test for at-home and point-of-care (POC) use. Cue said the test can differentiate between influenza and COVID-19 in about 25 minutes.

The Cue Flu + COVID-19 Molecular Test Cartridge uses a lower nasal swab sample and runs on the Cue Reader, which communicates test results digitally to the Cue Health App on a mobile device. 

"An accurate flu and COVID-19 test that can be done anywhere is a powerful tool. Combining this with the capability to treat on the same day enables a paradigm shift in respiratory diseases," said Ayub Khattak, Chairman and CEO of Cue Health. "We hope to enable this paradigm shift across the spectrum of infectious diseases and more with the many additional products in our pipeline."

Demand for COVID-19 testing has been all over the place, and Cue Health has seen this firsthand. In late June, the company had to lay off 170 people because of the decline in demand for COVID-19 testing.

Specifically, the company made the decision to cut personnel after the White House announced it was diverting more than $10 billion it had planned to spend on testing and personal protective equipment to buy new vaccines and treatments.

However, Cue’s trajectory in testing for the virus changed in August when it reported phenomenal revenue that exceeded guidance.

Cue’s story is not uncommon in the COVID-19 diagnostic space. Recall in July of 2021, that Abbott Laboratories eliminated about 310 jobs at its Westbrook, ME manufacturing facility. This happened around the time Abbott announced a leaner outlook for its rapid COVID-19 testing.

By April, the story would be different as COVID-19 testing surged to about $3.3 billion in 2021.  

About the Author(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].


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