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NEW YORK (GenomeWeb) – The US Food and Drug Administration today granted de novo clearance that permits marketing of Hologic's Aptima assay for Mycoplasma genitalium sexually-transmitted infection in men and women.

The FDA said that this is the first test it has authorized to test for M. genitalium, a slow-growing bacterium that is difficult to detect with traditional laboratory methods and is associated with inflammation of the urethra in men and inflammation of the cervix and infection of the reproductive organs in women.

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