HLTH - FDA approves Cue Health's at-home COVID-19 test

2023-06-06 17:24:32 ET

The U.S. Food and Drug Administration (FDA) on Tuesday said it had approved Cue Health's ( NASDAQ: HLTH ) at-home COVID-19 test, the first ever to be granted authorization through a traditional premarket review process.

HLTH stock was down 4% to $0.57 after hours.

HLTH's product, a type of test called a molecular nucleic acid amplification test, detects genetic material from the SARS-CoV-2 virus in nasal swabs.

The product had initially got an emergency use approval from the FDA in 2021, making it available to consumers without a prescription.

The FDA added that the approval was also the first ever at-home test cleared using a traditional premarket review process for any respiratory illness.

"This is part of the FDA's broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing," Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement .

The approval for HLTH comes after the U.S. in April signed a bill to end the COVID national emergency.

HLTH in a separate statement said that the test delivers results in just 20 minutes to connected devices and demonstrated an overall accuracy of 98%.

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