The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 at-home diagnostic self-test that provides rapid results.
What Happened: The Lucira COVID-19 All-In-One Test Kit is a molecular test that can be performed entirely at home and delivers results in under 30 minutes. Though the test has been granted an EUA, it will require a valid prescription, which could limit its initial use, according to the Associated Press.
Lucira Health is a California-based manufacturer. The company's single-use test kit allows users to swab a nasal sample themselves and then swirl in a vial of laboratory solutions that go into a portable device. Lights labeled positive or negative then display the results in 30 minutes.
The Lucira COVID-19 test grew out of the company's research to develop a similar at-home flu test.
Why It Matters: Health experts have been calling for options to allow self-testing to reduce turnaround times and bottlenecks at testing laboratories. Rapid test results aid in quickly quarantining the infected patient and trace contacts. Other rapid tests currently in use require a small special machine operated by a health professional, AP reports.
"Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them," FDA said in a statement. The test is authorized for use in doctor's offices and testing sites.
The release did not disclose the test's accuracy or the study results used by regulators to approve the test, AP noted.
The approval comes as a vaccine is yet to receive EUA for COVID-19. Pfizer Inc. (NYSE:PFE) and Moderna Inc. (NASDAQ:MRNA) have reported high efficiency for their coronavirus vaccine candidates in late-stage trials this month.