Laboratory Instrumentation

Hologic's Aptima HPV assay receives US FDA clearance for Panther system

PBR Staff Writer Published 24 July 2013

Hologic's Aptima HPV assay has received clearance from the US Food and Drug Administration (FDA) for use on its fully-automated Panther system, enabling laboratories to run multiple tests from a single specimen.

A nucleic acid amplified test, Hologic's Aptima HPV mRNA based assay can detect 14 high-risk strains of human papillomavirus (HPV) associated with cervical cancer and precancerous lesions.

Conducted with Hologic's ThinPrep liquid cytology specimen, the Aptima HPV test can be tested before and after it has been processed for cytology testing on the ThinPrep 2000 system.

The Panther system has been designed as a "sample-in-result-out" instrument and is capable of automating entire aspects of nucleic acid testing on a single, integrated platform, while eliminating batch processing.

Diagnostics senior vice president and general manager Rohan Hastie said the Panther system is an automation solution for a broad range of molecular diagnostic laboratories.

"Expanding the menu of available assays on Panther builds on our platform-centric strategy of delivering workflow efficiencies and revenue generating opportunities to our laboratory partners," Hastie added.

In 2008, the Aptima HPV assay was CE-marked and received FDA approval on the Hologic high- throughput Tigris system in 2011.