Hologic Assay Cleared by FDA

Bedford, Mass.-based diagnostics device company Hologic Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Aptima Trichomonas vaginalis assay on the fully-automated Panther system.

The Aptima assay initially was cleared for use on Hologic’s Tigris system in April 2011, and is the only FDA-approved amplified nucleic acid test designed 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 CEO of Hologic. “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 over the next year and beyond.”

The U.S. Centers for Disease Control estimates the sexually transmitted Trichomonas parasite causes 7.4 million infections in the United States annually. Trichomonas vaginalis has been linked to several serious health issues, including female infertility, pelvic inflammatory disease, premature births, low birth weight infants and increased risk of HIV transmission.

Current techniques for diagnosing and screening Trichomonas are limited compared with nucleic acid testing. Most testing currently is done through 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.

Hologic develops, manufactures and supplies diagnostic products, medical imaging systems, and surgical products in four core business units focused on diagnostics, breast health, gynecological surgical and skeletal health.