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FDA authorizes Quest Diagnostics/3M “real-time” Swine Flu molecular test combo

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The U.S. Food and Drug Administration granted emergency use authorization for the use of Quest Diagnostics’ Simplexa 24-hour Swine Flu test on equipment made by 3M, in a move aimed at boosting lab capacity for the test during flu season.

The molecular test, which uses “real-time” polymerase chain reaction technology to identify the RNA of the A/H1N1 influenza strain, is made by Cypress, Calif.-based Quest unit Focus Diagnostics. In July, the test was the first commercial diagnostics to gain FDA emergency authorization for use on equipment made by Roche and Applied Biosystems, according to a Quest press release.

Quest’s alliance with the Minneapolis conglomerate is aimed at boosting capacity at CLIA high-complexity labs in hospitals and regional facilities. The Simplexa test identifies the presence of H1N1 RNA from nasal or throat samples; results using the 3M cycler are available in 30 to 75 minutes, although transmitting the samples and returning results usually takes about 24 hours, Focus GM John Hurrell said in the statement. The test distinguishes between the H1N1 strain and seasonal flu strains.

The emergency use authorization does not mean the test has the FDA’s blessing. It’s not FDA-cleared or approved, according to a press release. The authorization was made to help labs cope with a surge in testing demand during flu season and is good only for the duration of the Swine Flu emergency.

The companies also inked a global distribution deal that will see Focus turn the Simplexa brand into its first line of molecular diagnostic test kits, designed for the 3M equipment. Quest said more Simplexa test kits, for other diagnoses, are in the works for 2010.

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