Hologic has received US Food and Drug Administration (FDA) approval for its Aptima HPV assay, which can be used on completely automated Panther systems.

To be performed with Hologic’s ThinPrep liquid cytology specimen, the assay can be tested both before and after it has been processed for cytology testing on the ThinPrep 2000 system.

As a nucleic acid amplified test that detects messenger RNA overexpressed from the E6 and E7 viral oncogenesin 14 high-risk strains of human papillomavirus (HPV) related to cervical cancer and precancerous lesions, Hologic’s Aptima HPV mRNA based assay has shown improved specificity in detection of the disease.

The addition of the Aptima HPV assay to the Panther menu is expected to widen the capabilities of laboratories in conducting multiple tests right in a single specimen, making it economical as well as a flexible and molecular testing platform.

"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."

The Panther system removes batch processing and automates various aspects of nucleic acid testing on one platform, in turn making it a ‘sample-in-result-out’ device.

Hologic Diagnostics senior vice-president and general manager Rohan Hastie said: "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."

The Aptima HPV assay has secured approval to screen women who are 21 years and older showing atypical squamous cells of undetermined significance (ASC-US) cervical cytology results, which will help in determining whether colposcopy is required.

It can also be used along with cervical cytology in order to find out high-risk HPV types in women 30 years and older.

This assay secured CE Mark in 2008 and US FDA approval on the Hologic high-throughput Tigris system in 2011.