Hologic’s Aptima HPV assay obtains Health Canada approval for use on Panther system

14 November 2013 (Last Updated November 14th, 2013 18:30)

Diagnostic and medical imaging systems provider Hologic has obtained Health Canada approval for use of its Aptima HPV assay on the company's completely automated Panther system.

Diagnostic and medical imaging systems provider Hologic has obtained Health Canada approval for use of its Aptima HPV assay on the company's completely automated Panther system.

Hologic's Aptima HPV mRNA based assay is a nucleic acid amplified test that is designed to detect messenger RNA overexpressed from the E6 and E7 viral oncogenes in 14 high-risk strains of human papillomavirus (HPV) associated with cervical cancer and precancerous lesions.

The Aptima HPV assay uses Hologic's ThinPrep liquid cytology specimens and is intended to be tested from the same sample that has been processed for cytology testing on the ThinPrep 2000 system.

The assay has demonstrated significantly improved specificity with no compromise in disease detection.

"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."

The addition of the Aptima HPV assay to the Panther menu allows the low- to high-volume laboratories to extend their capabilities to run multiple tests from a single specimen, on a cost-effective, highly flexible and fully automated molecular testing platform.

Panther system is a 'sample-in-result-out' instrument that eliminates the batch processing and automates all aspects of nucleic acid testing on a single, integrated platform.

Hologic Group vice-president diagnostics Dr Rohan Hastie said: "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."

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

It can also be used along with cervical cytology in order to assess the presence or absence of high-risk HPV types women 30 years and older.

In 2008, the Aptima HPV assay received CE-mark approval and earlier this year received Health Canada approval for use on Hologic's high-throughput Tigris testing platform.

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