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Dx Focus Apr 28, 2011: Clinical and Regulatory PCR and Nucleic Acid Testing News


Quest Diagnostics said this week that Simplexa-branded tests for Epstein-Barr virus and BK virus from Quest's Focus Diagnostics business have been CE marked for distribution to more than 30 European countries.

The test kits, which uses real-time PCR and run on the 3M Integrated Cycler, are intended to aid in the clinical management of immunocompromised patients, Quest said. The cycler is a compact, portable testing platform that can provide results in as little as an hour following sample extraction.

The EBV test is performed on whole blood specimens and the BK virus test is performed on either urine or plasma specimens to quantitatively detect the viruses, the company said.

Focus Diagnostics launched the Simplexa molecular product line in 2009 with a focus on influenza and respiratory syncytial virus. In May 2010, Simplexa was the first test kit to be cleared by the US Food and Drug Administration for aiding in the detection and differentiation of the 2009 H1N1 virus (PCR Insider, 5/25/10).

In December, Quest received 510(k) clearance from the FDA for the Simplexa Flu A/B and RSV tests after receiving CE Marks for the same tests in the fall (PCR Insider, 12/2/10).

Cepheid this week received clearance from the US Food and Drug Administration to market its Xpert Flu test on the GeneXpert system.

The test simultaneously detects and differentiates influenza A, influenza B, and the 2009 H1N1 influenza virus in about an hour, the company said.

"Xpert Flu empowers institutions with moderate complexity laboratories to have a molecular influenza test available to their physicians 24 hours a day," Cepheid CEO John Bishop said in a statement.

Xpert Flu is Cepheid's 11th Xpert test to receive FDA clearance, and will be available for shipment in two weeks. Xpert Flu is also available as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices.