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Dx Focus: FDA Approves Hologic Aptima HPV Assay for Panther System


The US Food and Drug Administration has approved Hologic's Aptima HPV assay for use on the company's fully automated Panther system.

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

The assay is a nucleic acid amplification test that detects mRNA overexpressed from the E6 and E7 viral oncogenes in 14 high-risk human papillomavirus types associated with cervical cancer and precancerous lesions. The test has demonstrated significantly improved specificity with no compromise in disease detection.

FDA approved the assay for two uses: to determine the need for referral to colposcopy for women 21 years and older whose cervical cytology results indicated atypical squamous cells of undetermined significance; and to use adjunctively with cervical cytology to screen women 30 years and older to assess the presence or absence of high-risk HPV types.

The Aptima HPV assay was CE marked in 2008 and received FDA approval on Gen-Probe's high-throughput Tigris system in 2011, prior to Hologic's acquisition of Gen-Probe.

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

Created to be a "sample-in-result-out" instrument, the Panther eliminates batch processing and automates all aspects of nucleic acid testing on a single, integrated platform.

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