Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
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
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Second emergency use authorization granted for a Quest H1N1 flu test
A second emergency use authorization request is granted to Quest's Focus Diagnostics unit by FDA Oct. 16 for an H1N1 influenza test. This one will allow Quest to market and offer its Simplexa Influenza A H1N1 (2009) test for use on the 3M Integrated Cycler. FDA granted an EUA July 24 to Quest for its Focus Diagnostics Influenza H1N1 (2009) real-time reverse transcription polymerase chain reaction test (1"The Gray Sheet" July 27, 2009). While 3M's Integrated Cycler diagnostic testing system is not FDA cleared or approved, when the Simplexa test is used on the 3M platform, it can provide increased capacity for 2009 H1N1 flu testing to a wide range of CLIA high-complexity laboratories, including hospital labs coping with a surge in testing demand this fall
Second emergency use authorization granted for a Quest H1N1 flu test
A second emergency use authorization request is granted to Quest's Focus Diagnostics unit by FDA Oct. 16 for an H1N1 influenza test. This one will allow Quest to market and offer its Simplexa Influenza A H1N1 (2009) test for use on the 3M Integrated Cycler. FDA granted an EUA July 24 to Quest for its Focus Diagnostics Influenza H1N1 (2009) real-time reverse transcription polymerase chain reaction test (1"The Gray Sheet" July 27, 2009). While 3M's Integrated Cycler diagnostic testing system is not FDA cleared or approved, when the Simplexa test is used on the 3M platform, it can provide increased capacity for 2009 H1N1 flu testing to a wide range of CLIA high-complexity laboratories, including hospital labs coping with a surge in testing demand this fall
Regulatory News In Brief
Herpes tests: FDA is amending a 2007 regulation that downclassified herpes simplex virus (HSV) serological assays to Class II to remove any reference to HSV assays other than type 1 and type 2 tests. In 1983, FDA classified the pre-amendment devices as Class III, then downclassified type 1 and type 2 tests in 2007 (1"The Gray Sheet" Jan. 16, 2006). Other HSV serological tests remained Class III, but because there are no other types of HSV tests on the market, FDA issued the Aug. 25 rule to prevent confusion. HSV assays were one of 27 types of pre-amendment devices that FDA had yet to downclassify or require PMAs for (2"The Gray Sheet" April 13, 2009). HSV test makers include Quest Diagnostics and Bio-Rad