June 6 (Reuters) – The U.S. Food and Drug Administration on Tuesday permitted Cue Health’s (HLTH.O) at-home COVID-19 check, the primary coronavirus check to get advertising authorization utilizing a conventional premarket evaluation, the company mentioned.

The FDA had granted emergency use authorization for the check in 2021 to make it accessible to customers with no prescription.

The company’s approval for the check comes practically a month after the U.S. ended the general public well being emergency standing for COVID, which has brought about greater than 1.1 million deaths within the nation.

This was the primary ever at-home check approved utilizing the standard evaluation course of for any respiratory sickness, the well being regulator added.

“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,” FDA official Jeff Shuren mentioned in a press release.

The check can detect all identified COVID variants of concern, the corporate mentioned.

Reporting by Raghav Mahobe in Bengaluru; Editing by Krishna Chandra Eluri

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