Leading health care products company Abbott Laboratories (ABT) said Monday it got 510(k) clearance from the U.S. Food and Drug Administration to market a molecular diagnostic test and instrument to simultaneously detect two sexually transmitted diseases, Gonorrhea and Chlamydia, including a new variant strain of the latter discovered in Sweden.The Abbott Park, Illinois-based company said it got independent clearances for both ‘Abbott RealTime
Chlamydia trachomatis, Neisseria gonorrhoeae-CT/NG- assay’ and the ‘Abbott m2000 System’. The company said that the two are required to be used together for the detection of the diseases from multiple specimen types including urine, urethral, vaginal and endocervical swabs.
Chlamydia trachomatis, Neisseria gonorrhoeae-CT/NG- assay’ and the ‘Abbott m2000 System’. The company said that the two are required to be used together for the detection of the diseases from multiple specimen types including urine, urethral, vaginal and endocervical swabs.
Further, Abbott said it also received clearance for its 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.
Abbott said it collaborated with international sexually transmitted diseases, or STD researchers to develop the chlamydia test, which was introduced in the European Union in 2008 to address a newly discovered variant strain initially identified in Sweden.
Chlamydia is a sexually transmitted disease in humans caused by the bacterium Chlamydia trachomatis, while bacterium Neisseria gonorrhoeae is responsible for causing Gonorrhea.
According to the Centers of Disease Control and Prevention or CDC, chlamydia remains the nation’s most frequently reported bacterial sexually transmitted disease. In 2008, more than 1.2 million chlamydial infections were reported to the CDC, an increase of 9% over the previous year. The company said that under reporting of the disease is huge because many people are unaware of their infections, and do not seek testing.
Abbot said that its RealTime CT/NG assay is an in vitro polymerase chain reaction assay for the direct, qualitative detection of the plasmid DNA of CT and the genomic DNA of NG. The assay may be used to test the following specimens from symptomatic individuals: female endocervical swab, clinician-collected vaginal swab, and patient-collected vaginal swab specimens; male urethral swab specimens; and female and male urine specimens.
Currently, Molecular or nucleic acid amplification tests are the standard method for detecting chlamydia and gonorrhea infections.
Klara Abravaya, senior director, research and development, Abbott Molecular, said “Because many people with chlamydia are co-infected with gonorrhea, it’s important to test for both diseases simultaneously. Left untreated, chlamydia and gonorrhea can lead to pelvic inflammatory disease, urethritis and sterility.”ABT is currently trading at $47.10, down $0.09 or 0.19%, on the NYSE.
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