FDA has granted Lucira Health emergency use authorization for the first take-home COVID-19 molecular test. The EUA for Lucira’s COVID-19 All-In-One Test Kit comes as the number of people testing positive for the virus is swelling throughout the U.S.
The Emeryville, CA-based company’s test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus.
The test is also authorized for use in point-of-care settings for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14-years-old.
In a release, Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health, said, “Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for FDA to address the pandemic. 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. We look forward to proactively working with test developers to support the availability of more at-home test options.”
The at-home-test is another milestone in testing during the pandemic. Abbott Laboratories made a significant contribution on the testing front when it won EUA for the BinaxNOW COVID-19 Ag Card for rapid detection of the infection. The test is touted as being able to get results back in five minutes.
In April, Rutger’s RUCDR Infinite Biologics along with Spectrum Solutions and Accurate Diagnostics Labs (ADL) had an impressive outing when it scored one of the first EUA’s for an application that uses saliva as the primary test biomaterial for the SARS-CoV-2 coronavirus.
Lucira’s test comes at a time when the number of COVID-19 cases in the U.S. has reached 11.7 million and deaths have reached 255,112, according to statistics from worldometers.info. The website notes about 7.1 million have recovered from the virus.