Cue Health Pauses Sales of COVID-19 Tests After FDA Warning Letter

The warning letter urges users and providers to throw the entire test cartridges in the trash due to the increased risk of false results.

Omar Ford

May 14, 2024

2 Min Read
Image Credit: Naeblys via iStock / Getty Images

At a Glance

  • Cue Health recently cut 49% of its staff.
  • Cue Health said it is currently evaluating the FDA's warning letter and determining its response.
  • The COVID-19 testing market is expected to decline at a compound annual growth rate of 21.2% from 2024 to 2030.

Cue Health has hit another roadblock. The San Diego, CA-based company has received a warning letter from FDA regarding its Emergency Use Authorized COVID-19 test.

In a release, FDA said it is warning home test users, caregivers, and healthcare providers not to use Cue Health’s COVID-19 Tests for Home and Over-the-Counter Use and its COVID-19 Test intended for patient care settings due to increased risk of false results.

The agency went on to say that it issued a Warning Letter to Cue Health on May 10, 2024, after an inspection revealed Cue made changes to these tests and these changes reduced the reliability of the tests to detect SARS-CoV-2 virus.

Cue Health said it is currently evaluating the letter and determining a response.

"Cue has decided to voluntarily and temporarily pause sales and distribution of its currently marketed EUA COVID-19 Test Cartridge, in light of FDA['s] Warning Letter," a Cue Health spokesperson told MD+DI. "Our team is actively working with FDA to quickly resolve the issues that were raised and is working with customers to reach appropriate resolutions. We are engaged with the FDA regarding future plans for distributing tests, and will provide an update in the near future."

The warning letter follows hot on the heels of  Cue Health announcing it would cut 49% of its staff – roughly 230 people. The company has been in the process of layoffs since 2022 – when COVID-19-testing first began to wane.

Related:DOD Gets Behind Cue Health's COVID-19 Test

The total COVID-19 testing market is valued at $33 billion and is expected to decline at a compound annual growth rate (CAGR) of 21.2% from 2024 to 2030, according to a report from GrandView Reseach.

Cue Health was founded in 2010 and raised $200 million in a 2021 IPO. The company won de novo authorization COVID-19 test in June of 2023. FDA noted this is the first COVID-19 test to obtain marketing authorization using a traditional premarket review, according to a report from Reuters.

However, the authorization came about a month behind WHO announcing that COVID-19 is no longer a public health emergency of international concern, although it still posed a global threat.

As of press time, Cue Health could not be reached for comment.

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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