Hologic, a developer of medical imaging systems and surgical products, has received approval for its Aptima HPV assay for use on its fully-automated Panther system from the US Food and Drug Administration (FDA).
The assay is a nucleic acid amplified test that detects messenger RNA (mRNA) overexpressed from the E6 and E7 viral oncogenes in 14 high-risk human papillomavirus (HPV) types associated with cervical cancer and precancerous lesions.
The Aptima HPV test is performed with the company’s ThinPrep liquid cytology specimen.
The addition of Aptima HPV assay to the fully-automated Panther system will help laboratories to conduct multiple tests from a single specimen.
Hologic said its Panther system will remove batch processing and automate all aspects of nucleic acid testing on a single, integrated platform.
Hologic senior vice president and general manager of diagnostics Rohan Hastie said that expanding the menu of available assays on Panther builds on the company’s platform-centric strategy of delivering workflow efficiencies and revenue generating opportunities to laboratory partners.
FDA approved the Aptima HPV assay to screen women aged 21 or more with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy.
The assay is also approved for use adjunctively with cervical cytology to screen women aged 30 and above to check the presence or absence of high-risk HPV types.
The assay, which received CE-mark in 2008, received FDA approval for usage on the company’s Tigris system in 2011.