Hologic Receives FDA Clearance for APTIMA Trichomonas for Use on PANTHER System
Hologic (NASDAQ: HOLX) today 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.
"The PANTHER System is a world class automation solution for a broad range of laboratories," said Rob Cascella, President and Chief Executive Officer. "Expanding the menu of available assays on this system builds on our strategy of delivering workflow and revenue efficiencies to our laboratory partners. We are excited to have APTIMA trichomonas available on PANTHER and look forward to further expanding our menu with high-value assays over the next year