News

Lumos Diagnostics' FebriDx point-of-care test will have to wait a bit longer to see the light of day in the U.S., as the Australian company announced (PDF) Monday that its 510(k) submission to the FDA has been rejected. The rapid test analyzes fingerstick blood samples within 10 minutes to determine whether an acute respiratory infection is viral or bacterial. Lumos Diagnostics' FebriDx point-of-care test will have to wait a bit longer to see the light of day in the U.S., as the Australian company announced (PDF) Monday that its 510(k) submission to the FDA has been rejected. The rapid test analyzes fingerstick blood samples within 10 minutes to determine whether an acute respiratory infection is viral or bacterial.