Hologic wins FDA approval for use of Trichomonas vaginalis assay on Panther system

The US Food and Drug Administration (FDA) has cleared the use of Hologic's amplified nucleic acid assay on the company's fully-automated Panther system.

Using endocervical or vaginal swabs and specimens, collected in Hologic’s ThinPrep vial from symptomatic or asymptomatic women, the APTIMA Trichomonas vaginalis assay detects Trichomonas vaginalis, a most common curable sexually transmitted infection.

Hologic president and chief executive officer Rob Cascella said the Panther system has been used in various laboratories as an automation solution.

"Expanding the menu of available assays on this system builds on our strategy of delivering workflow and revenue efficiencies to our laboratory partners," Cascella added.

"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 and beyond."

First cleared for use on Hologic’s TIGRIS System in April 2011, the APTIMA Trichomonas vaginalis Assay is the only FDA-cleared amplified nucleic acid test on the market specifically cleared to detect Trichomonas vaginalis, according to the company.