Talis withdraws COVID-19 test emergency use application, shares drop

Talis Biomedical

08/03/2021 15:29

** Shares of Talis Biomedical Corp  TLIS.O  fall as much as
8.8% to $13.35, lowest since debut over three weeks ago
    ** Co withdraws U.S. FDA Emergency Use Authorization (EUA)
application for its COVID-19 test in moderate setting
 urn:newsml:reuters.com:*:nGNX1QbcqR
    ** Plans to submit EUA application for the test in 'waived
setting', which reduces the risk for an incorrect result, early
in Q2 2021
    ** FDA informed TLIS in late February it could not ensure
the comparator assay used in the primary study had sufficient
sensitivity to support EUA application - TLIS
    ** Co says new study will address the FDA concerns
    

 (Reporting by Shreyasee Raj)
 ((Shreyasee.raj@thomsonreuters.com))