Influenza A H1N1 Real Time RT-PCR tests detect RNA of H1N1 influenza virus

Aug 21 2009

Focus Diagnostics, the infectious disease diagnostics business of Quest Diagnostics Incorporated (NYSE: DGX), today announced that its Influenza A H1N1 (2009) Real Time RT-PCR test is now available as a test kit for use by "high complexity" clinical laboratories in the U.S. The test qualitatively detects the RNA of the 2009 H1N1 influenza virus ("pandemic virus") from a patient's nasal, nasopharyngeal or throat specimen. In combination with clinical and epidemiological assessments, the test aids physicians in diagnosing patients infected with the pandemic virus rather than other influenza A strains.

"The availability of a quality test kit authorized by FDA for use during the pandemic emergency will contribute to the nation's capacity for accurate testing for the 2009 H1N1 influenza virus," said John Hurrell, Ph.D., vice president and general manager, Focus Diagnostics. "Expanded testing for this new virus could be critically important in aiding clinicians in determining which influenza A virus is causing a patient's illness should there be a surge in testing demand during the fall and winter flu season."

On July 24, the U.S. Food and Drug Administration ("FDA") announced it had granted emergency use authorization ("EUA") to the Focus Diagnostics test, the first granted to a commercial test for detecting the 2009 H1N1 influenza virus. On August 17, FDA informed Focus Diagnostics that it had issued an amended EUA for the company's test to reflect labeling clarifications regarding the contents of the test kit. According to the EUA, the test may be performed in laboratories certified under the U.S. Clinical Laboratory Improvement Amendments ("CLIA") to perform high-complexity tests and operating certain equipment.

In April 2009, the FDA granted two EUAs in connection with the CDC's RT-PCR diagnostic panel used by public health labs in the U.S. to detect the 2009 H1N1 influenza virus infection. In its EUA application to the FDA, Focus Diagnostics presented data involving more than 100 clinical specimens indicating that the Focus Diagnostics test agreed 100% with the CDC's RT-PCR test in identifying specimens as positive or negative for the pandemic virus.

For more information about Quest Diagnostics and influenza testing options, please visit www.FocusDx.com or www.QuestDiagnostics.com/2009H1N1.