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Chlamydia and Gonorrhea MDx Test from Abbott Cleared by FDA

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Abbott today announced it has received 510(k) clearance from the US Food and Drug Administration for its molecular diagnostic test and instrument for detecting gonorrhea and chlamydia, including a new strain of chlamydia recently discovered in Sweden.

The clearance covers the Abbott RealTime Chlamydia trachomatis/Neisseria gonorrhoeae, or CT/NG, assay and the Abbott m2000 system. The two must be used together as a system for detecting CT/NG from multiple specimen types, including urine, urethral, vaginal, and endocervical swabs, Abbott said in a statement.

The FDA also cleared Abbott's multi-Collect Specimen Collection unit for the collection and room-temperature transportation of multiple samples, including urine and endocervical, vaginal, and male urethral swab specimens, in one collection device.

The chlamydia test was introduced in the European Union in 2008 to address a new variant strain of the bacteria first identified in Sweden. No reports of the new strain have been reported in the US, but chlamydia remains the most frequently reported sexually transmitted disease in the US, according to the Centers for Disease Control and Prevention, with more than 1.2 million infections reported in 2008, a nine percent increase from the year before.