FDA makes rare 'mis­in­for­ma­tion' com­ment on Lu­ci­ra's EUA for its at-home Covid-19 and flu test

The FDA has re­leased a rare com­ment on what hap­pened dur­ing Lu­ci­ra Health’s EUA fil­ing for the first at-home Covid-19 and flu test as part of the agency’s “com­mit­ment to ad­dress mis­in­for­ma­tion,” just weeks af­ter the EUA was au­tho­rized and the com­pa­ny filed for Chap­ter 11 bank­rupt­cy.

The FDA did not spell out ex­act­ly what it meant by mis­in­for­ma­tion and de­clined to com­ment. But the state­ment comes af­ter Feb­ru­ary tweets from one of Lu­ci­ra’s co-founders call­ing out the agency for the length and tim­ing of the EUA clear­ance, as well as its bank­rupt­cy fil­ing, which said the de­lay in EUA fi­nan­cial­ly hit the com­pa­ny.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER