Abbott Receives FDA Clearance for Molecular Diagnostic Test for Detection of Chlamydia and Gonorrhea Infections

DES PLAINES, Ill., June 28 /PRNewswire-FirstCall/ — Abbott
(NYSE: ABT) announced today that it has received 510(k)
clearance from the U.S. Food and Drug Administration to market a
new, sensitive molecular diagnostic test and instrument to
simultaneously detect two of the nation’s most prevalent sexually
transmitted diseases (STDs), gonorrhea and chlamydia, including a
new variant strain of chlamydia recently discovered in Sweden.

Abbott received independent 510(k) clearances for both the
Abbott RealTime Chlamydia trachomatis/Neisseria
gonorrhoeae (CT/NG) assay and the Abbott m2000 System.
 They are required to be used together as a system for the
detection of CT/NG from multiple specimen types including urine,
urethral, vaginal and endocervical swabs.  Also cleared was
the Abbott multi-Collect Specimen Collection Kit, a unique
device for collection and room-temperature transportation of
multiple samples, including urine samples and endocervical, vaginal
and male urethral swab specimens, in one collection device.

“Because many people with chlamydia are co-infected with
gonorrhea, it’s important to test for both diseases
simultaneously,” said Klara
Abravaya, Ph.D., senior director, research and development,
Abbott Molecular.  “Left untreated, chlamydia and gonorrhea
can lead to pelvic inflammatory disease, urethritis and
sterility.”

Abbott worked in collaboration with leading international STD
researchers to develop the chlamydia test, which was introduced in
the European Union in 2008 to address a newly discovered variant
strain of the bacteria initially identified in ‘/>”/>

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