The Food and Drug Administration has granted an emergency use authorization for the first at-home coronavirus testing kit that does not require sending samples to a laboratory. The new test was developed by Lucira Health and can return results in just 30 minutes.
“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
The new test is available by prescription only and comes with everything needed to return the results. Users will have to take a nasal swab from both nostrils and then place it in a vial of chemicals, which they must swirl around. The vial is then inserted into a portable device that will process the sample. Within 30 minutes, it will provide the results. Lucira Health estimates that the testing kit will cost $50.
Under the emergency use authorization, the FDA said that any health care provider who prescribes the test must report the results to public health authorities.
“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 the 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,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “We look forward to proactively working with test developers to support the availability of more at-home test options.”
Photo: Getty Images