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IQuum Gets FDA Emergency Use OK for H1N1 Molecular Assay

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – IQuum, a privately held molecular diagnostics firm, has gained Emergency Use Authorization from the US Food and Drug Administration for its Liat Influenza A/2009 H1N1 Assay.

The nucleic acid test can be performed from sample to result in 26 minutes. According to the firm, the Liat assay can detect and differentiate 2009 H1N1 influenza viral RNA from nasopharyngeal swab samples and has shown 100 percent agreement with an EUA comparator assay.

IQuum also said it is the fastest nucleic acid test authorized by the FDA to date.

The FDA authorization allows the test to be performed in CLIA labs that are certified to run "moderate complexity" tests, as well as labs certified to run "high complexity" tests. The "moderate complexity" authorization means the test can be used in many near-patient settings in hospitals, the firm said.

Marlborough, Mass.-based IQuum is the latest of several firms to receive FDA EUA for their 2009 H1N1 assays.

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