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Cypress’ Focus Diagnostics releases H1N1 flu test kit

The first FDA-approved test for detecting the virus will be marketed to commercial laboratories in the U.S.

By Susan BelknappPublished: August 20, 2009 10:55 AM

Cypress-based Focus Diagnostics, the infectious disease diagnostics business of Madison, N.J.-based Quest Diagnostics Inc., announced Thursday that it would be launching the Influenza A H1N1 (2009) Real Time RT-PCR test for detecting the flu strain to commercial laboratories.

The test kit is now available 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. The test aids physicians in diagnosing patients infected with the virus as opposed to other influenza A strains using clinical and epidemiological assessments.

"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," says John Hurrell, Ph.D., vice president and general manager of 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."


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