Hologic's (HOLX) APTIMA Receives FDA Clearance
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Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX) announced that the U.S. Food and Drug Administration (FDA) has cleared for marketing its APTIMA Trichomonas vaginalis Assay on the Company's fully-automated PANTHER System.
The APTIMA Trichomonas vaginalis Assay, first cleared for use on Hologic's TIGRIS System in April 2011, remains the only FDA-cleared amplified nucleic acid test on the market specifically cleared to detect Trichomonas vaginalis, the most common curable sexually transmitted infection in the United States. The assay may be used to test clinician-collected endocervical or vaginal swabs, and specimens collected in Hologic's ThinPrep vial from symptomatic or asymptomatic women.
Trichomonas is a sexually transmitted parasite estimated by the U.S. Centers for Disease Control to cause 7.4 million infections in the U.S. annually. Trichomonas vaginalis has been linked to several serious health outcomes including female infertility, pelvic inflammatory disease, premature births, low birth weight and increased risk of HIV transmission.
Current techniques for the diagnosis and screening of Trichomonas have limitations in comparison to nucleic acid testing. Most testing is currently done via culture methods, which are slow and less sensitive than molecular assays, or a "wet mount," which requires the microscopic examination of a sample shortly after it is collected and is even less sensitive than culture.
The APTIMA Trichomonas vaginalis Assay, first cleared for use on Hologic's TIGRIS System in April 2011, remains the only FDA-cleared amplified nucleic acid test on the market specifically cleared to detect Trichomonas vaginalis, the most common curable sexually transmitted infection in the United States. The assay may be used to test clinician-collected endocervical or vaginal swabs, and specimens collected in Hologic's ThinPrep vial from symptomatic or asymptomatic women.
Trichomonas is a sexually transmitted parasite estimated by the U.S. Centers for Disease Control to cause 7.4 million infections in the U.S. annually. Trichomonas vaginalis has been linked to several serious health outcomes including female infertility, pelvic inflammatory disease, premature births, low birth weight and increased risk of HIV transmission.
Current techniques for the diagnosis and screening of Trichomonas have limitations in comparison to nucleic acid testing. Most testing is currently done via culture methods, which are slow and less sensitive than molecular assays, or a "wet mount," which requires the microscopic examination of a sample shortly after it is collected and is even less sensitive than culture.
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