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FDA Publishes Guidance Document for H1N1 Dx

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has published a guidance document intended to help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus.

The FDA said that it "recognizes that it may not be possible to generate complete clinical validation data that would normally be included in an application," but the guidance document outlines the information that the agency believes should be included in an application for marketing.

The FDA has yet to clear for marketing any diagnostic tests specifically for the 2009 H1 N1 influenza virus. However, it has granted Emergency Use Authorization for a few tests to be used as an aid in diagnosing the virus. Among the firms to receive EUA's for their tests are Focus Diagnostics, which is owned by clinical lab giant Quest Diagnostics, Gen-Probe's Prodesse business, and clinical lab Diatherix Laboratories. The first assay to receive the EUA was developed by the US Centers for Disease Control and Prevention and was cleared in April.

Several other firms also have submitted or plan to submit an EUA request with the FDA for their assays.

According to the guidance document, "When reviewing an EUA request for an [in vitro diagnostic], FDA considers the scientific evidence of test performance, as well as the risks and benefits of each test when used to detect 2009 H1N1 Influenza virus or to be used as a first step in an algorithm for the identification of 2009 H1N1."

The guidance document also provides a description of the types of information that should be included in an EUA application and the format in which it should be filed with the agency. The guidance document can be viewed here.

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