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Hologic Gets FDA Clearance for Trichomonas Assay

NEW YORK (GenomeWeb News) – Hologic announced today that the US Food and Drug Administration has cleared for marketing the firm's Aprima Trichomonas vaginalis Assay to run on the Panther System.

The assay was previously cleared by the FDA for use on Gen-Probe's Tigris System in April 2011. According to Bedford, Mass.-based Hologic, the assay remains the only FDA-cleared amplified nucleic acid test on the market for detecting Trichomonas.

The Panther System, a fully automated and integrated molecular testing platform aimed at low- and medium-volume labs, was cleared for marketing by the FDA in May 2012.

"Expanding the menu of available assays on this system builds on our strategy of delivering workflow and revenue efficiencies to our laboratory partners," Hologic President and CEO Rob Cascella said in a statement.

Gen-Probe was acquired by Hologic for $3.7 billion last year.