Hologic, a manufacturer of diagnostic and medical imaging systems, has obtained Health Canada approval for its Aptima HPV assay for use on the company's fully automated Panther system.
Aptima HPV assay has been designed to detect messenger RNA overexpressed from the E6 and E7 viral oncogenes in 14 high-risk human papillomavirus (HPV) strains associated with cervical cancer and precancerous lesions.
The Panther system eliminates batch processing and automates all aspects of nucleic acid testing on a single, integrated platform.
Addition of the nucleic acid amplified test to the Panther menu extends the capability of low- to high-volume laboratories to run multiple tests from a single specimen on a fully automated molecular testing platform.
Aptima HPV test is performed with the company’s ThinPrep liquid cytology specimens, which are routinely used for Pap testing, and can be tested before or after it has been processed for cytology testing on the ThinPrep 2000 system.
Aptima HPV assay has been approved to screen women 21 years and older with atypical squamous cells of undetermined significance cervical cytology results to determine the need for referral to colposcopy.
The assay is also approved to use adjunctively with cervical cytology to screen women 30 years and older to assess the presence or absence of high-risk HPV types.
Hologic diagnostics group vice president Dr Rohan Hastie noted the company’s Panther system is a world-class automation solution for a broad range of molecular diagnostic laboratories.
"Expanding Panther’s menu of available assays builds on our platform-centric strategy of delivering workflow efficiencies and revenue-generating opportunities to our laboratory partners," Dr Hastie added.
The Aptima HPV assay obtained CE Mark approval in 2008 and received Health Canada approval earlier 2013 for use on Hologic’s high-throughput Tigris testing platform.