FDA Bids Farewell to Cepheid's COVID Test Era
Published Date: 6/26/2025
Notice
Summary
The FDA is ending the emergency approval for Cepheid’s Xpert Xpress COVID-19 test because the company asked them to. This means the test can no longer be used under emergency rules, so labs and healthcare providers need to switch to other authorized tests. No extra costs or deadlines for the public, but it’s a heads-up for anyone using this test.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Cepheid Xpert Xpress EUA Revoked
The FDA revoked the Emergency Use Authorization for Cepheid’s Xpert Xpress SARS-CoV-2 test at the company's request. That means labs and health care providers can no longer use this test under emergency rules and must switch to other authorized COVID-19 tests.
No Public Costs or Deadlines
The FDA says there are no extra costs or new deadlines for the public because of this revocation. This notice is mainly a heads-up for people and organizations that were using the Cepheid test.
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