San Diego Union-Tribune

San Diego’s Cue Health had the first FDA-approved home COVID-19 test. Now the agency says to throw them out.

The U.S. Food and Drug Administration told consumers Monday to throw out any at-home COVID-19 tests made by San Diego biotech Cue Health, because they could give users false results. Early in the ...
Seeking Alpha

Cue Health Launches Cue Care™ Nationwide to Provide Same-Day, At-Home, Test-to-Treatment Service for COVID-19

Consult virtually and on-demand with a healthcare professional about their test result; Obtain an e-prescription - if medically indicated - for a medication to treat the virus; and Get the medication ...
STAT

Cue Health, Covid-19 testing company, is shutting down

In an abrupt change of course from plans earlier in the month, at-home test maker Cue Health is laying off all of its employees and shutting down as of Friday, May 24. The company, which grew to ...
Monthly Prescribing Reference

FDA Says Cue Health COVID-19 Tests May Be Unreliable

An inspection revealed Cue Health made changes to the tests that reduce their reliability to detect SARS-CoV-2 virus. The Food and Drug Administration (FDA) has issued a warning letter to Cue Health ...
FierceBiotech

FDA chides Cue Health for changing its home COVID test, tells consumers to throw them out

The FDA is recommending that anyone who still has any home COVID tests left from Cue Health should throw them away. According to the agency, its inspectors discovered that the diagnostics company had ...
San Diego Union-Tribune

San Diego COVID-19 test maker Cue Health – once worth $2.3B – lays off entire company and shuts down

Cue Health, the once high-flying San Diego biotech supplying rapid COVID-19 test kits to the NBA and Google, is laying off all employees and shutting down on Friday. Cue’s closure comes a week after ...
STAT

Cue Health’s Covid-19 tests could give false results, FDA warns

The Food and Drug Administration warned consumers Monday to not use Cue Health’s at-home Covid-19 tests. This follows an FDA warning letter to the company last week that said Cue was not following the ...
KRQE Blogs

Throw out COVID-19 tests made by Cue Health, FDA warns

SAN DIEGO (KSWB/KUSI) — The U.S. Food and Drug Administration is warning people not to use COVID-19 tests that were manufactured by a California-based health care company. Cue Health, headquartered in ...
MobiHealthNews

FDA gives Cue Health first EUA for at-home, OTC COVID-19 molecular testing

The FDA has issued its first emergency use authorization for a COVID-19 molecular diagnostic test that does not require a prescription and can be used at home. Developed by Cue Health, the Cue ...
MobiHealthNews

Cue Health receives first-ever de novo authorization for at-home COVID-19 test

Home diagnostics company Cue Health announced its received FDA de novo authorization for its at-home COVID-19 test, dubbed the Cue COVID-19 Molecular Test. The Cue COVID-19 Molecular Test detects ...
MD&M East

Cue the End Credits for This COVID-19 Test Maker

After years of financial struggle post-COVID-19’s diagnostic boom, Cue Health seems to have begrudgingly hung the white flag of defeat, announcing recently that it would shut down operations and lay ...