Regulatory News In Brief

Pandemic flu test: FDA granted emergency use authorization July 24 to a third diagnostic test for detecting the HINI pandemic flu virus, Quest Diagnostics Focus Diagnostics Influenza H1N1 (2009) real-time reverse transcription polymerase chain reaction test. The authorization, enabled by the 2004 Project BioShield law, permits Quest to distribute the test to clinical labs from its California-based Focus Diagnostics subsidiary. The assay can amplify viral genetic material obtained from nose or throat swabs, or nasal discharges, in patients with symptoms of respiratory infection. The previous two EUA tests were developed by the federal government