Lucira's home test for flu and COVID-19 gets U.S. FDA nod for OTC use (updated)

Lucira Health

27/02/2023 14:12

(Adds details, background and shares)
       Feb 27 (Reuters) - Lucira Health  LHDX.O  said on Monday
the U.S. Food and Drug Administration (FDA) had granted
emergency use authorization for its combination diagnostic test
for COVID-19 and the flu, making it the first to be available
over-the-counter.
    The test — called Lucira COVID-19 & Flu Home Test — is a
single-use, at-home rapid test kit that provides results from
self-collected nasal swab in about 30 minutes.
    Shares of the medical test maker rose more than four-fold to
66 cents in premarket trade.
    The FDA's authorization, which came on Friday, allows the
test to be purchased without a prescription and performed
completely at home by individuals aged 14 years or older or
collected by an adult for children two years or older.
    The development comes days after Lucira filed for bankruptcy
protection in the United States, and said it intended to pursue
a sale of its business.
   "Unfortunately, we were unable to bridge what became a
protracted authorization cycle time within our current capital
structure and it remained unclear to us when the regulatory
authorization would come through," said CEO Erik Engelson.
        The company was hoping to launch the test during autumn
last year — in time for the 2022 flu season — but remains
confident that the test will play a key role in upcoming periods
of severe respiratory disease.
    Lucira is also seeking a strategic or financial partner to
resume the manufacturing and development of additional home
diagnostic tests. 

 (Reporting by Bhanvi Satija and Sriparna Roy in Bengaluru;
Editing by Shailesh Kuber and Uttaresh Venkateshwaran)
 ((Bhanvi.Satija@thomsonreuters.com; Outside U.S. +91
9873062788;))