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FDA Approves Hologic's Aptima HPV 16, 18/45 Genotype Assay

NEW YORK (GenomeWeb News) – Hologic today said that the US Food and Drug Administration has approved its Aptima HPV 16 18/45 Genotype Assay for use on the Tigris platform.

The assay was developed by Gen-Probe, which Hologic acquired this past summer, and it is the first test that FDA has approved for genotyping human papillomavirus types 16, 18, and/or 45, which are associated with about 80 percent of all invasive cervical cancers globally, Hologic said. It is performed from the company's ThinPrep liquid cytology specimens, which are collected for pap testing.

The assay is intended for women with positive test results with the Aptima HPV Assay and intended for two uses. One is as an adjunct with the Aptima HPV Assay in women at least 30 years of age in combination with cervical cytology in order to evaluate the presence or absence of specific high-risk genotypes 16, 18, and/or 45.

The Aptima HPV Assay was approved by FDA a year ago and received CE marking in 2008.

It also is intended as an adjunct for the Aptima HPV Assay for women at least 21 years of age with atypical squamous cells of undetermined significance cervical cytology results in order to evaluate the presence or absence of specific high-risk HPV genotypes 16, 18, and/or 45.

The test is not for use as a deterrent against colposcopies, Hologic said.

The company anticipates launching the assay during Hologic's first quarter of fiscal 2013, which began a few weeks ago.

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