Lucira today announced the US launch of its at-home combination COVID-19 and flu test, the first of its kind, following the February emergency use authorization (EUA) from the Food and Drug Administration (FDA).
The biotechnology company, based in Emeryville, California, also announced that the test is now cleared for use as a point-of-care test in Australia.
In earlier clinical trials, the molecular test has performed similarly for both COVID and flu when assessed against polymerase chain reaction (PCR) tests. Lucira's combo test also marks the availability of the first over-the-counter test for flu. The test involves nasal swabbing and runs on two AA batteries, delivering a result in about 30 minutes. The introductory price is $34.99, and the product is available on the company's website.
US consumers will, for the first time ever, be able to diagnose if they have COVID-19 or Flu A or B while at home.
Erik Engelson, MBS, MS, the company's president and chief executive officer, said, "US consumers will, for the first time ever, be able to diagnose if they have COVID-19 or Flu A or B while at home. With one-touch access to telehealth via our Lucira Connect web platform, they can now get onto the path to treatment and recovery within hours of receiving a test result from the comfort of home.”
Last month as the company received the EUA from the FDA it announced that it filed for bankruptcy due to the prolonged review process. The company said it had produced inventory for an autumn 2023 launch.