fashion -WSS

fashion

author：comprehensive 2025-09-27 12:10:46 - browse：46213

A product image of the Cue reader COVID-19 home use test — Businesswire via AP

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 conditions stipulated in the emergency use authorizations for its tests.

The FDA letters said the tests could give false results. Specifically, the agency said that the company had changed how the electrochemical signals within the test device were generated, received, and interpreted — changes the FDA has not authorized. These changes decreased the stability of the tests and might lead to false results, the agency said.

The FDA warnings come near what might be the end of a spectacularly bumpy ride for the company. When Cue went public in 2021, it was valued at nearly $3 billion. It supplied tests for the NBA’s 2020 “bubble,” leading a Trump administration official to proclaim that if the test was “good enough for LeBron,” the administration would bring it to the American people — and it did, in a $481 million deal.

STAT+ Exclusive Story

Already have an account? Log in

This article is exclusive to STAT+ subscribers

Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+.

Already have an account? Log in

Monthly

$39

Totals $468 per year

$39/month Get Started

Totals $468 per year

Starter

$30

for 3 months, then $39/month

$30 for 3 months Get Started

Then $39/month

Annual

$399

Save 15%

$399/year Get Started

Save 15%

11+ Users

Custom

Savings start at 25%!

Request A Quote Request A Quote

Savings start at 25%!

2-10 Users

$300

Annually per user

$300/year Get Started

$300 Annually per user

View All Plans

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： New air purifier tech could be key to improving indoor air quality
Next article： ASCO Daily Recap: CAR

WSS

Why we need mandatory labeling of GMO products

Lawsuit challenges CMS nursing home minimum staffing rule

Hospitals need to get ahead of regulations on climate change

Stopping antidepressants leads to symptoms for 1 in 6 patients

Fight over Supreme Court dialysis ruling puts kidney patients at risk

ASCO Daily Recap: CAR

hotspot

fashion

This article is exclusive to STAT+ subscribers

Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+.

entertainment

Food as medicine: CMS rules hamper 'prescribing' of fruits, veggies

Illumina board agrees to spin off Grail, as divestment plans proceed

Biden outlines 'new path' to provide student loan relief after Supreme Court rejection

Stroke rates rising, especially in working

How one medical school became remarkably diverse

Sutter Health’s antitrust win overturned by appeals court

Heart attack and stroke risk calculators need revising

Eli Lilly’s Zepbound improved liver scarring in mid

Medicare details structure of new drug price negotiation program

Take antibiotics after sex, CDC recommends for certain risk groups

focus

The Bio Revolution is changing business and society

The world needs the new pandemic treaty

Medical students need to learn the potent medicine of empathy

Duchenne drug from Nippon Shinyaku fails in rare confirmatory trial

The HPV vaccine prevents cancer in men, too. Why do so few people get it?

STAT wants to know your pick for a great summer read or listen

explore

hotspot

entertainment

hotspot