Lucira Health, Inc. has been granted an emergency use authorization (EUA) by the U.S. Food and Drug Administration for prescription at-home and point of care use of its COVID-19 diagnostic at-home self-testing kit that provides results within 30 minutes.

The at-home test kit, the first of its kind, is a single-use test designed to detect the novel coronavirus (SARS-CoV-2 virus), which causes COVID-19, by detecting genetic material from the virus and amplifying it. Currently, there are two kinds of tests to detect if someone is infected with COVID-19: antigen tests and molecular tests.

“Molecular tests like Lucira’s are 40 to 60 times more sensitive than antigen tests, and are considered highly accurate for determining if someone is infected,” Lucira Health CEO Erik Engelson said.

The Lucira™ COVID-19 All-In-One Test Kit will be available for individuals served by Sutter Health in Northern California, and Cleveland Clinic Florida in Miami-Ft. Lauderdale.

Their COVID-19 All-In-One Test Kit is expected to be available to a limited number of customers through the first half of 2021.

The testing device is small enough to fit in the palm of a hand and while the process can take up to 30 minutes, it can take as few as 11 minutes for a positive test result.

Dr. John Chou, a principal investigator on the Lucira Health Community Testing Study submitted to the FDA, said that the lack of rapid testing has been an issue globally.

The COVID-19 All-In-One Test Kit includes the test unit base, a sample vial, nasal swab, instructions, two AA batteries and one disposal bag. The at-home test kit has been in development for over half a decade and was first developed as a flu test until Lucira leveraged that research and development into a test kit for COVID-19 as cases began to rise earlier this year.

“We believe this highly mobile test can make a big difference by providing lab-quality results expeditiously and conveniently. Early, accurate detection is vital to delivering appropriate care and controlling the pandemic,” Dr. Chou said.

Lucira At A Glance

  • Private company
  • Founded in 2013
  • Headquartered in Emeryville, California (USA)
  • Goodwin IP client since March 2019