Hologic gains FDA approval for Aptima HPV assay for use on the Panther system

Hologic said Tuesday that the FDA cleared its Aptima HPV assay for use on the company's fully-automated Panther system. The assay was approved to screen for the need for colposcopy in women at least 21 years of age whose cervical cytology results are atypical squamous cells of undetermined significance. The test was also approved for use adjunctively with cervical cytology to screen women aged 30 years and older to assess the presence or absence of high-risk human papillomavirus (HPV) types.

Specifically, Hologic said the assay is a nucleic acid-amplified test that detects mRNA over-expressed from the E6 and E7 viral oncogenes in 14 high-risk strains of HPV associated with cervical cancer and precancerous lesions. The company noted that the test "has demonstrated significantly improved specificity with no compromise in disease detection."

The assay is performed with the company's ThinPrep liquid cytology specimen and can be tested before and after it has been processed for cytology testing on the ThinPrep 2000 system. Hologic noted that the assay, which gained the CE mark in 2008 and received FDA approval on the Hologic high-throughput Tigris system in 2011, extends the capability of laboratories to run multiple tests from a single specimen.

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