H1N1

Quest's Focus Diagnostics gets CE Mark for Simplexa EBV and BK virus tests; Cepheid gets FDA nod for Xpert Flu test.

Quest Diagnostics has received 510(k) clearance from the US Food and Drug Administration for its Focus Diagnostics Simplexa Flu A/B and RSV test on the 3M Integrated Cycler.

Biosearch has licensed from the US Centers for Disease Control and Prevention new H1N1 influenza probes and primers for more sensitive and specific H1N1 detection assays.

In a research paper published online this week, the scientists demonstrated that Cepheid's Xpert Flu A panel test represents "a great improvement" over methods currently employed by a majority of clinical labs to detect 2009 H1N1 influenza, but still falls a bit short when compared to the gold standard method.

In separate deals, the Singapore firm acquired rights to assays for dengue/chikungunya, Mycobacterium tuberculosis, and H1N1.

Focus and 3M are also developing a version of the influenza A/B/RSV test, as well as a test for herpes simplex virus, that would be suitable for use in moderate-complexity laboratories under the Clinical Laboratory Improvement Amendments act.

Around a dozen H1N1 tests have gained EUA approval since the FDA gave its first EUA last April for CDC's PCR-based test. However, only two of these assays have received 510(k) clearance, which allows them to be used beyond the EUA.

The studies surmise that multiplex PCR respiratory virus assays, such as those offered by EraGen, Seegene, Luminex, and Qiagen, perform as well or better than traditional fluorescent antibody tagging and cell culture methods at detecting respiratory viruses in clinical specimens.

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